Trending Topics & Drug Approvals: November 2025 - Prime Therapeutics
Trending Topics & Drug Approvals: November 2025
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The ACIP recommendation that for children under four years of age, immunization for varicella should occur through a standalone vaccination rather than with the combination of a measles, mumps, rubella, varicella (MMRV) vaccine was also adopted by the CDC. This decision was based on data showing that healthy 12 to 23 month olds have an increased risk of febrile seizures (approximately five more per 10,000 doses) seven to 10 days following vaccination with the combined MMRV vaccine compared with receiving separate immunizations for varicella and measles, mumps and rubella (MMR). The standalone varicella vaccine is administered at the same time as the MMR vaccine. Previously, parents/caregivers could choose to administer the MMRV instead of separate MMR and varicella vaccines, if preferred.
Results from the randomized, double-blind, placebo-controlled, multicenter, Phase 3 SURPASS-PEDS trial (n=99) have been published in The Lancet. In pediatric patients 10 to < 18 years of age with youth-onset type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and/or basal insulin, weekly subcutaneous (SC) tirzepatide (Mounjaro) demonstrated superiority to placebo in lowering hemoglobin A1c (HbA1c) at week 30 (-2.23% versus 0.05%, respectively; estimated treatment difference, -2.28%; 95% confidence interval [CI], -2.87 to -1.69; p<0.0001). Significant decreases in body mass index (BMI) were also observed with tirzepatide compared to the placebo group (5 mg: -7.4%, 10 mg: -11.2%, placebo: -0.4%). Safety findings were comparable to those observed in adults with the most common adverse events with tirzepatide being gastrointestinal (GI)-related and mild to moderate in severity.
A systematic review and meta-analysis of 18 randomized clinical trials (RCTs) that compared glucagon-like peptide-1 (GLP-1) receptor agonists to placebo in 1,402 patients six to 17 years of age with obesity, overweight, prediabetes or T2DM was published in JAMA Pediatrics. The study found that over a median treatment duration of 0.51 years (interquartile range, 0.25 to 1 years), GLP-1 receptor agonists significantly reduced HbA1c (-0.44%), fasting glucose (-9.92 mg/dL), body weight (-3.02 kg), BMI (-1.45 kg/m²) and systolic blood pressure (-2.73 mm Hg). Patients who received GLP-1s exhibited a significantly increased risk for GI adverse effects compared to placebo patients, but a significant difference in the rates of discontinuation, depression, suicidal ideation/behaviors and hepatobiliary disorders was not detected.
The FDA has announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program. Voucher recipients will receive a decision regarding approval within one to two months after filing a complete application. Products that received a voucher include agents for the following conditions: infertility, type 1 diabetes, nicotine vaping addiction, deafness, blindness, pancreatic cancer and porphyria. Additionally, ketamine and Augmentin XR received vouchers for domestic manufacturing of a critical drug for anesthesia and a common antibiotic, respectively.
The FDA approved a Boxed Warning for ciltacabtagene autoleucel (Carvykti) for immune effector cell-associated enterocolitis (IEC-EC) following clinical trial and postmarketing reports of these events. Patients experiencing IEC-EC had severe or prolonged diarrhea, abdominal pain and weight loss requiring total parenteral nutrition weeks to months after receiving Carvykti. Patients received supportive care and immunosuppressive therapies (e.g., corticosteroids) for management of IEC-EC; however, fatalities occurred due to GI perforation and sepsis. The FDA states the benefits continue to outweigh potential risks for the indicated population and has included updated overall survival (OS) data from the CARTITUDE-4 study in the clinical studies section of the product label. This data demonstrates that at an estimated median follow-up of 33.6 months, a prespecified second interim analysis found a significant improvement in OS with Carvykti compared to standard therapy. The product label was also updated to include risk of T cell lymphoma of the GI tract and GI perforation.
The Agency has confirmed the contaminated children's cough and cold products in India have not been shipped to the U.S. The Indian health authority has also stated that these products were not exported to any other country. Products are contaminated with diethylene glycol (DEG) and ethylene glycol (EG).
The FDA has provided an update regarding the risk of inadvertent neuraxial administration of tranexamic acid (Cyklokapron, generic). Inadvertent neuraxial (intrathecal or epidural) administration of tranexamic acid, instead of the intended local anesthetic (e.g., bupivacaine, lidocaine, mepivacaine and ropivacaine), has led to serious patient outcomes, such as prolonged hospitalization and death. As a result, the FDA is requiring updates to the product labeling to (1) add a Boxed Warning communicating the risk of medication errors, (2) add a statement indicating neuraxial injection is contraindicated and (3) update the Dosage/Administration section to clarify the product is only for intravenous (IV) administration.
The Agency has announced a new pilot prioritization program for review of Abbreviated New Drug Applications (ANDAs). To be eligible for priority review, applicants are required to conduct bioequivalence testing in the U.S. and manufacture the products in the U.S. using active pharmaceutical ingredients that are from exclusively domestic sources.
Roche's Elecsys pTau181 test has received clearance as the first blood-based biomarker test approved as an aid in the initial assessment for Alzheimer's disease and other causes of cognitive decline in the primary care setting. It is intended for use in patients ≥ 55 years of age with signs/symptoms or complaints of cognitive decline and measures phosphorylated Tau (pTau) 181 protein in human plasma. The results of this minimally invasive test are for use in conjunction with other clinical information and can aid in identification of patients in early stages of cognitive decline who do not yet have Alzheimer's-related amyloid pathology.
The CDC published a Morbidity and Mortality Weekly Report (MMWR) on influenza-associated hospitalizations during the last influenza season (2024–25), which was a high severity season based on a surveillance sample of the U.S. population. The cumulative rate of influenza-associated hospitalization was the highest reported since the 2010–11 influenza season with the proportion of patients requiring intensive care unit (ICU) care reaching nearly 17% and with 6.1% of patients requiring invasive mechanical ventilation. Approximately a third of hospitalized patients had received an annual influenza vaccine. Furthermore, the 2024–25 influenza season had 280 influenza-associated pediatric deaths, the highest number since child deaths became nationally notifiable in 2004 (with the exception of the 2009–10 influenza A[H1N1]pdm09 pandemic).
An MMWR was published by the CDC on pediatric influenza-associated encephalopathy (IAE) and acute necrotizing encephalopathy. During the 2024–25 influenza season, 109 pediatric IAE cases were identified, with 55% of affected children being previously healthy. Thirty-seven IAE cases were further subcategorized as a severe form of IAE known as acute necrotizing encephalopathy (ANE), which is characterized by rapid neurologic decline and a poor prognosis (41% of ANE patients passed away). Nearly three-fourths of IAE patients required admission to the ICU and 19% of IAE patients passed away. Of the IAE patients eligible for an updated influenza vaccine, only 16% had received the current version.
Interim effectiveness estimates of 2025 Southern hemisphere influenza vaccines in preventing influenza-associated outpatient and hospitalized illness were published in an MMWR by the CDC. During March to September 2025, across eight Southern hemisphere countries, seasonal influenza vaccination reduced influenza-associated outpatient visits by 50.4% and hospitalization by 49.7%.
The CDC reports as of Oct. 28, 2025, that there were 1,648 confirmed cases of measles in the U.S. in 2025. Cases include, 440 (27%) in individuals less than five years of age, 656 (40%) in those five to 19 years of age, 545 (33%) in those ≥ 20 years of age and seven with unknown age; 92% of cases are among individuals with unvaccinated or unknown vaccination status. Johns Hopkins' Bloomberg School of Public Health is monitoring the measles outbreak in real-time through their International Vaccine Access Center (IVAC). On Oct. 31, 2025, IVAC reported 1,659 total cases in the U.S. in 2025.
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The American Gastroenterological Association (AGA) has released a clinical practice guideline on management of gastroparesis, including recommendations for diagnosis and effective treatment (e.g., pharmacologic and procedural interventions). Diagnosis requires a four hour gastric emptying test; metoclopramide or erythromycin is appropriate for initial drug therapy. Shared decision making between patients and physicians is required for other treatment recommendations.
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The American Society of Nephrology (ASN) has published kidney health guidance on potassium and phosphorous food additives. Clinical management requires individualization and is determined by patients' medical conditions, motivation, health literacy and access to resources.
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The Society for Maternal-Fetal Medicine has published guidelines on diagnosis and management of right and left heart failure during pregnancy and postpartum. Grade recommendations are provided for managing patients with heart failure with reduced ejection fraction who are continuing pregnancy.
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An MMWR on clinical recommendations for use of injectable lenacapavir (Yeztugo) as HIV preexposure prophylaxis (PrEP) has been released. The CDC PrEP Guidelines Work Group strongly recommends Yeztugo as an HIV PrEP option in persons weighing ≥ 35 kg who would benefit from PrEP. Yeztugo is an HIV-1 capsid inhibitor FDA-approved for PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing ≥ 35 kg who are at risk for HIV-1 acquisition. It is administered as a SC maintenance regimen every six months following an initiation schedule with both oral and SC Yeztugo.
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The CDC has published an MMWR on antimicrobial treatment and prophylaxis recommendations for naturally acquired infections and bioterrorism response of tularemia which is caused by the gram-negative coccobacillus, Francisella tularensis. Although tularemia occurs naturally in the U.S., due to its low infectious inoculum, it is considered a potential bioterrorism agent. Fluoroquinolones (ciprofloxacin or levofloxacin) and doxycycline are considered first-line treatment options for outbreaks of any size; recommendations are also provided for special populations (neonates, breastfeeding infants, lactating mothers, immunocompromised patients and geriatric individuals).
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The European Association for the Study of Diabetes (EASD) has published an evidence-based clinical practice guideline on assessing/managing diabetes distress among adults. EASD recommends that health care professionals (HCPs) ask about and assess diabetes distress as part of routine, effective person-centered care. For managing distress related to diabetes, conditional recommendations support psychological and psychoeducational interventions with recommendations varying depending on diabetes type and intervention category.
Drug Approvals
Specialty
Sept. 25, 2025 – imlunestrant (Inluriyo)
- New Drug Application (NDA) approval; Assessment Aid, Fast Track; the U.S. Food and Drug Administration (FDA) also approved the companion diagnostic device, Guardant360 CDx assay, to identify patients with breast cancer with estrogen receptor-1 (ESR1) mutations eligible for treatment
- Estrogen receptor antagonist
- Indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
- Oral tablet: 200 mg
- Recommended dosage is 400 mg orally once daily at approximately the same time each day, on an empty stomach (at least two hours before or one hour after food), until disease progression or unacceptable toxicity; pre/perimenopausal women and men should receive a gonadotropin-releasing hormone (GnRH) agonist according to current clinical practice standards
- Approval was based on a randomized, open-label, active-controlled, multicenter study (EMBER-3; n=874); in the subset of patients with ESR1 mutations (n=256), a statistically significant improvement in median progression-free survival (PFS) was observed with imlunestrant compared to investigator’s choice of endocrine therapy with fulvestrant or exemestane (5.5 months versus 3.8 months, respectively; hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.46 to 0.82; p=0.0008)
- Elacestrant (Orserdu) is also an estrogen receptor antagonist and is FDA-approved for the treatment of postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy; Orserdu and Inluriyo are recommended in the National Comprehensive Cancer Network (NCCN) guidelines as category 2A other recommended regimens in the first-line or subsequent-line setting for patients with ESR1-mutated, hormone receptor (HR)-positive, HER2-negative disease
- Inluriyo is available from Eli Lilly
Sept. 25, 2025 – paltusotine (Palsonify)
- NDA approval; Orphan Drug; first once daily oral therapy FDA-approved to treat acromegaly
- Somatostatin receptor agonist
- Indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option
- Oral tablets: 20 mg and 30 mg
- Recommended initial dosage is taken once daily with water on an empty stomach (at least six hours after a meal and at least one hour before the next meal); during initiation the dose may be temporarily reduced, if needed, based on tolerability; following resolution of adverse reactions, resume at the initial dose; based on insulin-like growth factor (IGF-1) levels, can be further increased to the maximum dose after two to four weeks
- Approval was based on two randomized, double-blind, placebo-controlled, Phase 3 studies (PATHFNDR-1; n=58; PATHFNDR-2; n=111); PATHFNDR-1 demonstrated, at week 36, 83.3% of paltusotine patients compared with 3.6% of placebo patients maintained biochemical control, defined as maintaining IGF-1 ≤ 1 × upper limit of normal [ULN], at the end of the core phase (mean of weeks 34 and 36), equating to an odds ratio of 127; p<0.0001; these patient had been switched from injected somatostatin receptor ligands (octreotide or lanreotide) and were randomized to receive paltusotine or placebo; in PATHFNDR-2, a significantly greater proportion of paltusotine patients than placebo patients achieved biochemical control after 24 weeks (56% versus 5%, respectively; p<0.0001)
- Other FDA-approved therapies for acromegaly include somatostatin analogs (e.g., subcutaneous [SC] lanreotide [Somatuline Depot], SC octreotide [Sandostatin], intramuscular [IM] octreotide [Sandostatin LAR], octreotide oral delayed-release capsules [Mycapssa], IM pasireotide [Signifor LAR]) and SC growth hormone receptor antagonist pegvisomant (Somavert)
- Palsonify is available from Crinetics
Sept. 26, 2025 – immune globulin intravenous (IV), human-kthm (Qivigy)
- Biologics License Application (BLA) approval
- Immune globulin
- Indicated for treatment of adults with primary humoral immunodeficiency; this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies
- Solution for injection: 10% liquid solution containing 100 mg/mL in two presentations (5 g immune globulin per 50 mL and 10 g immune globulin per 100 mL in single-dose vials)
- Recommended dosage is given by IV infusion as a weight-based dose every three to four weeks; product labeling details the initial and maintenance infusion rates (based on tolerability) for the first and subsequent infusions; administered by a health care professional (HCP) with monitoring of the patient’s vital signs throughout the infusion with slowing or stopping the infusion, as needed, if adverse reactions occur
- Approval was based on an open-label, prospective 12-month clinical study (CARES10; n=47) in which all patients received immune globulin IV, human-kthm on a three or four week infusion cycle; the study demonstrated no acute serious bacterial infections (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess and osteomyelitis/septic arthritis) during the study
- There are many other FDA-approved immune globulin products given IV that are similar: immune globulin IV, human-stwk (Alyglo); immune globulin IV, human–slra (Asceniv); immune globulin IV, human (Bivigam, Flebogamma, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Privigen); immune globulin IV, human-ifas (Panzyga); immune globulin IV, human-dira (Yimmugo)
- Boxed Warnings for thrombosis, renal dysfunction and acute renal failure
- Qivigy is expected to be available from Kedrion Biopharma in early 2026
Sept. 30, 2025 – remibrutinib (Rhapsido)
- NDA approval; Priority Review; first FDA-approved Bruton tyrosine kinase inhibitor (BTKi) for chronic spontaneous urticaria (CSU)
- BTKi
- Indicated for the treatment of CSU in adults who remain symptomatic despite H1 antihistamine treatment; not indicated for other forms of urticaria
- Oral tablet: 25 mg
- Recommended dosage is taken twice daily, with or without food, swallowed whole with water; treatment should be interrupted for three to seven days pre- and post-surgery depending upon the type of surgery and the risk of bleeding
- Approval was based on two identical, multicenter, randomized, double-blind, placebo-controlled clinical trials (REMIX-1 and REMIX-2; n=925) that evaluated the change from baseline in the urticaria activity score during a seven-day period (UAS7) (includes severity scores for itch and hives; scores range from 0 to 42, higher scores indicate greater severity) at week 12; the remibrutinib group had a significantly greater decrease in the UAS7 than the placebo group (difference in least-squares mean change versus placebo, -6.22; p<0.001 in REMIX-1; -7.68; p<0.001 in REMIX-2)
- Other FDA-approved biologic therapies which share this indication include the interleukin-4 receptor alpha antagonist dupilumab (Dupixent) and the anti-immune globulin E (anti-IgE) antibody omalizumab (Xolair); both of these products are indicated for adults as well as pediatric patients ≥ 12 years of age and are administered via SC injection; Dupixent can be administered by a patient or caregiver following proper training; as Xolair carries a Boxed Warning for anaphylaxis, selection of patients for self-administration requires careful consideration in order to mitigate the risk for anaphylaxis (requires initiation in a health care setting); Rhapsido provides a unique mechanism of action for this indication and is administered orally
- Rhapsido is available from Novartis
Oct. 7, 2025 – nerandomilast (Jascayd)
- NDA approval; Orphan Drug, Priority Review; first preferential inhibitor of phosphodiesterase 4B (PDE4B) for this indication
- Phosphodiesterase 4 (PDE4) inhibitor
- Indicated for treatment of idiopathic pulmonary fibrosis in adults
- Oral tablets: 9 mg and 18 mg
- Recommended dosage is taken orally twice daily approximately 12 hours apart with or without food; tablets should be swallowed whole or dispersed in water
- Approval was based on two randomized, double-blind, placebo-controlled trials (FIBRONEER-IPF; n= 1,177; study 2; n=147); in FIBRONEER-IPF, the adjusted mean in forced vital capacity (FVC) at week 52 was -115 mL in the nerandomilast 18 mg group, -139 mL in the nerandomilast 9 mg group and -184 mL in the placebo group, demonstrating a significantly smaller decline in FVC with nerandomilast compared to placebo; in the second trial at week 12, patients receiving nerandomilast also demonstrated a reduction in FVC decline compared to patients who received placebo
- Other similarly indicated FDA-approved therapies include pirfenidone (Esbriet), a pyridone taken orally three times daily, and nintedanib (Ofev), a kinase inhibitor taken orally twice daily (Ofev also carries additional indications)
- Jascayd is available from Boehringer Ingelheim
Sept. 26, 2025 – denosumab-qbde (Enoby)
- BLA approval; denosumab-qbde (Enoby) is a biosimilar to reference drug denosumab (Prolia); seventh FDA-approved biosimilar to Prolia (one of which is interchangeable)
- RANK ligand inhibitor
- Indicated for the treatment (1) of postmenopausal women with osteoporosis at high risk for fracture; (2) to increase bone mass in men with osteoporosis at high risk for fracture; (3) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; (4) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer and (5) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer (same indications as Prolia)
- Solution for injection: 60 mg/mL single-dose prefilled syringe (same as Prolia)
- Recommended dosage is given every six months as a SC injection administered by an HCP; patients should take calcium and vitamin D daily
- Boxed Warning for severe hypocalcemia in patients with advanced kidney disease
- Product will be available from Richter/Hikma with launch timeframe to be determined (TBD)
Sept. 26, 2025 – denosumab-qbde (Xtrenbo)
- BLA approval; denosumab-qbde (Xtrenbo) is a biosimilar to reference drug denosumab (Xgeva); seventh FDA-approved biosimilar to Xgeva (one of which is interchangeable)
- RANK ligand inhibitor
- Indicated for (1) prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; (2) treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity and (3) treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy (same indications as reference drug Xgeva)
- Solution for injection: 120 mg/1.7 mL in a single-dose vial (same as Xgeva)
- Recommended dosage is administered every four weeks SC by an HCP; additional doses are given on days eight and 15 for the first month of therapy in patients being treated for giant cell tumor of bone or hypercalcemia of malignancy; calcium and vitamin D should be taken as needed to treat/prevent hypocalcemia
- Product will be available from Richter/Hikma with launch timeframe TBD
Oct. 2, 2025 – aflibercept-boav (Eydenzelt)
- BLA approval; aflibercept-boav (Eydenzelt) is a biosimilar to reference drug aflibercept (Eylea); sixth FDA-approved biosimilar to Eylea (two of which are interchangeable)
- Vascular endothelial growth factor (VEGF) inhibitor
- Indicated for (1) neovascular (wet) age-related macular degeneration (AMD); (2) macular edema following retinal vein occlusion (RVO); (3) diabetic macular edema (DME) and (4) diabetic retinopathy (DR) (Eylea carries an additional indication for retinopathy of prematurity)
- Solution for injection: 2 mg (0.05 mL of 40 mg/mL) solution in single-dose prefilled syringes and single-dose vials (same as Eylea)
- Recommended dosage is administered by intravitreal injection by an HCP every four weeks; some indications allow for dosing every eight weeks following the initial dosing period
- Product will be available from Celltrion with launch timeframe TBD
Sept. 25, 2025 – evinacumab-dgnb (Evkeeza)
- Regeneron; angiopoietin-like 3 (ANGPTL3) inhibitor; Priority Review
- Expanded indication: to include use in pediatric patients ≥ 1 year of age as an adjunct to diet and exercise and other low-density lipoprotein-cholesterol (LDL-C)-lowering therapies to reduce LDL-C in patients with homozygous familial hypercholesterolemia (HoFH); previously, Evkeeza was indicated as an adjunct to other LDL-C-lowering therapies for the treatment of adult and pediatric patients ≥ 5 years of age with HoFH
- Administered as a weight-based IV infusion once monthly (every four weeks) by an HCP; the product labeling details the maximum diluent volume by patient body weight with the final concentration of diluted solution being between 0.5 mg/mL and 20 mg/mL depending on the patient’s current body weight
Sept. 26, 2025 – guselkumab (Tremfya)
- Janssen; interleukin-23 (IL-23) antagonist
- Expanded indication: pediatric patients ≥ 6 years of age who weigh ≥ 40 kg with (1) moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and (2) active psoriatic arthritis; previously, it was only indicated for adults with these conditions
- Administered as a SC injection at week zero, week four and every eight weeks thereafter; for psoriatic arthritis, may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (e.g., methotrexate)
- Other indications are detailed in the product label
Oct. 2, 2025 – atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza)
- Genentech; atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody and hyaluronidase is an endoglycosidase; Orphan Drug, Priority Review, Project Orbis; approval marks the first combination therapy for first-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC)
- New indication: in combination with lurbinectedin (Zepzelca) for maintenance treatment of adults with ES-SCLC whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab/hyaluronidase-tqjs, carboplatin and etoposide
- Recommended Tecentriq dosage is administered by IV infusion every two, three or four weeks by an HCP until disease progression or unacceptable toxicity
- Recommended dosage of Tecentriq Hybreza is administered SC every three weeks by an HCP until disease progression or unacceptable toxicity
- Other indications are detailed in the product label
Oct. 2, 2025 – lurbinectedin (Zepzelca)
- Jazz; alkylating drug; Assessment Aid, Orphan Drug, Priority Review, Project Orbis; approval marks the first combination therapy for first-line maintenance treatment of ES-SCLC
- New indication: in combination with Tecentriq or Tecentriq Hybreza for maintenance treatment of adults with ES-SCLC whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab/hyaluronidase-tqjs, carboplatin and etoposide
- Recommended dosage is based on body surface area (BSA) and is administered by IV infusion every 21 days by an HCP until disease progression or unacceptable toxicity
- Other indication: treatment of adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy (Accelerated Approval)
Oct. 3, 2025 – pemetrexed (Axtle)
- Avyxa; folate analog metabolic inhibitor
- New indication: in combination with pembrolizumab (Keytruda) and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations
- Administered as an IV infusion based on BSA after Keytruda and prior to platinum chemotherapy on day one of each 21-day cycle for four cycles; after platinum-based therapy is complete, Axtle with or without Keytruda should be given until disease progression or unacceptable toxicity; product labeling lists dosage regimens for concurrent medications (e.g., folic acid, vitamin B12, dexamethasone)
- Other indications are detailed in the product label
Oct. 7, 2025 – golimumab (Simponi)
- Janssen; tumor necrosis factor (TNF) blocker
- Expanded indication: to include pediatric patients weighing ≥ 15 kg with moderately to severely active ulcerative colitis (UC); previously, only indicated for UC in adults with moderately to severely active UC who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine or 6-mercaptopurine
- Administered as a SC injection at weeks zero, two, six and every four weeks thereafter; pediatric patients ≥ 15 kg to < 40 kg have a lower dosage than adults and pediatric patients ≥ 40 kg; patients (≥ 12 years of age) or caregivers may administer following proper training
- Other indications are detailed in the product label
Oct. 8, 2025 – cemiplimab-rwlc (Libtayo)
- Regeneron; programmed death receptor-1 (PD-1) blocking antibody; Assessment Aid, Priority Review, Real-Time Oncology Review; first immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence
- New indication: adjuvant treatment of adults with CSCC at high risk of recurrence after surgery and radiation
- Administered as an IV infusion every three weeks for 12 weeks followed by maintenance dosing every six weeks or administered every three weeks as initial and maintenance dosing; administered by an HCP; continued until disease recurrence, unacceptable toxicity or up to 48 weeks of total therapy
- Other indications are detailed in the product label
Oct. 10, 2025 – sodium phenylbutyrate (Olpruva)
- Acer; nitrogen-binding agent; new 0.5 g and 1 g pellets in packets for reconstitution as oral suspension also received FDA approval in conjunction with the expanded indication; already approved in pellet packets in the strengths of 2 g, 3 g, 4 g, 5 g, 6 g and 6.67 g
- Expanded indication: for pediatric patients ≥ 1 year of age weighing ≥ 7 kg as an adjunct to standard of care (including dietary management) for the chronic management of urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS); previously, it was only indicated for adult and pediatric patients weighing ≥ 20 kg and with a BSA of ≥ 1.2 m²
- A new limitation of use was also added stating it is not recommended for patients < 1 year of age due to volume of free water required for daily administration
- Administered as a weight-based dose orally or by a gastrostomy tube in three to six divided doses per day, taken with food; combine with dietary protein restriction and, in some cases, amino acid supplementation (e.g., essential amino acids, arginine, citrulline) and protein-free calorie supplements
Oct. 16, 2025 – adalimumab-aaty (Yuflyma)
- Celltrion; TNF blocker; interchangeable biosimilar to Humira
- New indications: addition of non-infectious intermediate, posterior, and panuveitis in pediatric patients ≥ 2 years of age and moderate to severe hidradenitis suppurativa (HS) in adolescent patients ≥ 12 years of age
- Administered via SC injection every other week with dosage dependent on body weight for uveitis; administered SC every other week following an initial loading phase with dosage dependent on body weight for HS; patients/caregivers may administer after proper training
- Other indications are detailed in the product label
Oct. 16, 2025 – adalimumab-adaz (Hyrimoz)
- Sandoz; TNF blocker; interchangeable biosimilar to Humira
- New indications: addition of non-infectious intermediate, posterior and panuveitis in pediatric patients ≥ 2 years of age and moderate to severe HS in adolescent patients ≥ 12 years of age
- Administered via SC injection every other week with dosage dependent on body weight for uveitis; administered SC every other week following an initial loading phase with dosage dependent on body weight for HS; patients/caregivers may administer after proper training
- Other indications are detailed in the product label
Oct. 16, 2025 – adalimumab-adbm (Cyltezo)
- Boehringer Ingelheim; TNF blocker; interchangeable biosimilar to Humira
- New indications: addition of non-infectious intermediate, posterior and panuveitis in pediatric patients ≥ 2 years of age and moderate to severe HS in adolescent patients ≥ 12 years of age
- Administered via SC injection every other week with dosage dependent on body weight for uveitis; administered SC every other week following an initial loading phase with dosage dependent on body weight for HS; patients/caregivers may administer after proper training
- Other indications are detailed in the product label
Oct. 16, 2025 – adalimumab-atto (Amjevita)
- Amgen; TNF blocker; interchangeable biosimilar to Humira
- New indications: addition of non-infectious intermediate, posterior and panuveitis in pediatric patients ≥ 2 years of age and moderate to severe HS in adolescent patients ≥ 12 years of age
- Administered via SC injection every other week with dosage dependent on body weight for uveitis; administered SC every other week following an initial loading phase with dosage dependent on body weight for HS; patients/caregivers may administer after proper training
- Other indications are detailed in the product label
Oct. 16, 2025 – adalimumab-ryvk (Simlandi)
- Alvotech; TNF blocker; interchangeable biosimilar to Humira
- New indications: addition of non-infectious intermediate, posterior and panuveitis in pediatric patients ≥ 2 years of age and moderate to severe HS in adolescent patients ≥ 12 years of age
- Administered via SC injection every other week with dosage dependent on body weight for uveitis; administered SC every other week following an initial loading phase with dosage dependent on body weight for HS; patients/caregivers may administer after proper training
- Other indications are detailed in the product label
Oct. 16, 2025 – tofacitinib (Xeljanz)
- Pfizer; Janus kinase (JAK) inhibitor; expanded indication applies to the immediate release tablets and oral solution only; the extended-release tablets (Xeljanz XR) are indicated for adults with active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers
- Expanded indication: active PsA in patients ≥ 2 years of age who have had an inadequate response or intolerance to one or more TNF blockers; previously only approved in adults for this indication
- Administered as an oral dose based on body weight taken twice daily
- Other indications are detailed in the product label
Oct. 17, 2025 – obinutuzumab (Gazyva)
- Genentech; CD20-directed cytolytic antibody; Breakthrough Therapy
- New indication: treatment of adults with active lupus nephritis (LN) who are receiving standard therapy
- Administered as an initial IV infusion, followed by dosing at weeks two, 24, 26 and every six months thereafter; administered by an HCP with appropriate medical support for the management of severe infusion-related reactions that can be fatal
- Other indications are detailed in the product label
Oct. 17, 2025 – tezepelumab-ekko (Tezspire)
- AstraZeneca; thymic stromal lymphopoietin (TSLP) blocker
- New indication: add-on maintenance treatment of adult and pediatric patients ≥ 12 years of age with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP)
- Administered via SC injection every four weeks; the vial and prefilled syringe formulations require administration by an HCP and the prefilled pen can be administered by the patient/caregiver following proper training
- Other indication: for the add-on maintenance treatment of adult and pediatric patients ≥ 12 years of age with severe asthma
Traditional
Sept. 24, 2025 – lidocaine topical system (Bondlido)
- 505(b)(2) NDA approval; other lidocaine products indicated for pain associated with post-herpetic neuralgia (PHN) include lidocaine patch 5% (Lidoderm) and lidocaine topical system 1.8% (ZTlido)
- Amide local anesthetic
- Indicated in adults for relief of pain associated with PHN
- Topical system: 10%
- Recommended dosage is to apply to intact skin to cover the most painful area; the prescribed number of topical systems (maximum of two) should be applied only once for up to 12 hours in a 24-hour period; to ensure adherence to the skin, apply firm pressure for 20 seconds
- Product will be available from MedRX in the first half of 2026
Sept. 26, 2025 – clotrimazole otic solution (Clotic)
- 505(b)(2) NDA approval; Orphan Drug, Priority Review
- Azole antifungal
- Indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients ≥ 18 years of age
- Limitation of use stating it has only been studied in patients with intact tympanic membranes; use is not recommended for treatment of otomycosis in patients with perforated tympanic membranes
- Otic solution: 1% solution that delivers approximately 0.17 mL of solution equivalent to 1.7 mg of clotrimazole supplied in a single-dose vial
- Recommended dosage is to instill the contents of one single-dose vial into the affected ear canal twice daily, morning and evening, preferably 12 hours apart for 14 consecutive days
- Product will be available from Carwin in early 2026
Oct. 7, 2025 – furosemide injection (Lasix Onyu)
- 505(b)(2) NDA approval; furosemide is also FDA-approved as an oral tablet (Lasix, generics), an oral solution (generic), a solution for IV or IM injection (generic) and a solution for SC injection (Furoscix On-Body Infusor); Lasix Onyu is a drug-device combination that provides a high-concentration formulation of furosemide for use with an on-body infusor (reusable unit + disposable unit) allowing for at-home treatment
- Loop diuretic
- Indicated for the treatment of edema in adults with chronic heart failure
- Injection: 80 mg per 2.67 mL in a single-dose prefilled cartridge co-packaged with a single-use Disposable Unit of the Infusor; reusable unit is an electromechanical device containing the battery, motor and electronic components and can be used for 48 treatments
- The Infusor is pre-programmed to deliver a bolus dose over the first hour, then a lower dose per hour for the subsequent four hours; used once or twice daily as needed for edema (maximum of two infusions per 24 hours); the Infusor can be applied by a patient or caregiver to the stomach following proper training; the patient should have access to a bathroom for up to eight hours after starting the infusion due to frequent urination; for short term use only, not intended for chronic use and should be replaced with oral diuretics as soon as practical
- Product will be available from SQ Innovation in the fourth quarter of 2025
Oct. 22, 2025 – fosfomycin injection (Contepo)
- 505(b)(2) NDA approval; Priority Review; fosfomycin is also FDA-approved as oral granules for solution (generic) indicated for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis
- Epoxide antibacterial
- Indicated for the treatment of patients ≥ 18 years of age with complicated urinary tract infections (cUTI) including acute pyelonephritis caused by susceptible isolates of E. coli and Klebsiella pneumoniae
- To decrease the development of drug-resistant bacteria and maintain effectiveness of Contepo and other antibacterial drugs, only use for treating infections that are proven or strongly suspected to be caused by bacteria
- Injection: 6 grams of fosfomycin in a single-dose vial for reconstitution and further dilution
- Recommended dosage is 6 grams every eight hours by IV infusion administered by an HCP in patients with an estimated creatinine clearance (CLcr) > 50 mL/minute; the duration of treatment is up to 14 days and is guided by infection severity and clinical status of the patient; estimated CLcr should be monitored with dosage adjustments accordingly
- Product will be available from Meitheal with launch timeframe TBD
Oct. 4, 2025 – roflumilast cream (Zoryve)
- Arcutis; PDE4 inhibitor; the FDA also approved a new 0.05% strength cream for the expanded pediatric population
- Expanded indication: for pediatric patients ≥ 2 years of age for the topical treatment of mild to moderate atopic dermatitis (0.05% cream); previously approved for this use in patients ≥ 6 years of age (0.15% cream)
- Apply topically once daily to affected areas and rub in completely
- Other indication: topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients ≥ 6 years of age (0.3% cream)
Oct. 9, 2025 – alirocumab (Praluent)
- Regeneron; proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor
- Expanded indication: indication to reduce the risk of major adverse cardiovascular (CV) events (MACE) (e.g., CV death, myocardial infarction [MI], stroke, unstable angina requiring hospitalization) in adults has been expanded to include adults who are at increased risk for these events; Praluent was previously indicated to reduce the risk of MACE in adults with established CV disease
- Expanded indication: as an adjunct to diet and exercise to reduce LDL-C in (1) adults with hypercholesterolemia; (2) adults and pediatric patients ≥ 8 years of age with heterozygous familial hypercholesterolemia (HeFH) and (3) adults with HoFH; these indications previously stated that Praluent was to be (1) used as an adjunct to diet, alone or in combination with other LDL-C lowering therapies, in adults with primary hyperlipidemia, including HeFH; (2) used as an adjunct to diet and other LDL-C-lowering therapies for pediatric patients ≥ 8 years of age with HeFH and (3) used as an adjunct to other LDL-C-lowering therapies in adults with HoFH
- Administered as a SC injection every two weeks or every four weeks; patients/caregivers may administer after proper training
Oct. 10, 2025 – risperidone extended-release injectable suspension (Uzedy)
- Teva; atypical antipsychotic
- New indication: as monotherapy or as adjunctive therapy to lithium or valproate for maintenance treatment of bipolar I disorder in adults
- Administered as a SC injection once monthly into the abdomen or upper arm by an HCP with dosing dependent on current formulation and dose of risperidone (e.g., daily oral risperidone or every-two-week dosing of long-acting IM injection)
- Other indication: treatment of schizophrenia in adults
Oct. 17, 2025 – semaglutide (Rybelsus)
- Novo Nordisk; glucagon-like peptide-1 (GLP-1) receptor agonist; only oral GLP-1 FDA-approved to reduce the risk of MACE in adults with type 2 diabetes mellitus (T2DM)
- New indication: to reduce the risk of MACE (CV death, non-fatal MI or non-fatal stroke) in adults with T2DM who are at high risk for these events
- Administered orally once daily with dosage dependent on if using the R1 or R2 formulation
- Other indication: as an adjunct to diet and exercise to improve glycemic control in adults with T2DM
First generic drug launches
- Xiromed launched a generic vaginal insert to Ferring’s Endometrin
- Progesterone; indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology (ART) treatment program for infertile women
- Recommended dosage is administered vaginally two or three times daily starting the day after oocyte retrieval and continuing for up to 10 weeks total duration
- Annual sales for Endometrin in 2024 were $20 million
Oct. 20, 2025 – glycerol phenylbutyrate (Ravicti)
- Par/Endo launched a generic oral liquid to Horizon’s Ravicti
- Nitrogen-binding agent; indicated for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone; must be used with dietary protein restriction and, in some cases, dietary supplements
- Recommended initial dosage is based on BSA; plasma ammonia levels should be used to determine dosage titration
- Annual sales for Ravicti in 2024 were $528 million
CD cluster of differentiation
EGFR epidermal growth factor receptor
HIV human immunodeficiency virus
HIV-1 human immunodeficiency virus-1
mRNA messenger ribonucleic acid
RANK receptor activator of nuclear factor-kappa B
U.S. United States
Editor-In-Chief: Maryam Tabatabai, PharmD
Executive Editor: Anna Schreck Bird, PharmD
Deputy Editors: Nicole Kjesbo, PharmD, BCPS; Olivia Pane, PharmD, CDCES
All brand names are property of their respective owners.