Quarterly Drug Approvals: July 2025

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
clesrovimab-cfor	Enflonsia	Merck	RSV LRTD prevention (neonates and infants)	IM	June
garadacimab-gxii	Andembry	CSL Behring	Hereditary angioedema prophylaxis (≥ 12 years of age)	SC	June
immune globulin infusion (human) 10% solution	Gammagard Liquid ERC	Takeda	Primary humoral immunodeficiency (≥ 2 years of age)	IV, SC	June
lenacapavir oral tablet and SC injection	Yeztugo	Gilead	HIV-1 PrEP (patients weighing ≥ 35 kg)	Oral, SC	June
nitisinone oral tablet	Harliku	Cycle	Alkaptonuria	Oral	June
hydrocortisone oral solution	Khindivi	Eton	Adrenocortical insufficiency (≥ 5 years of age)	Oral	May
treprostinil inhalation powder	Yutrepia	Liquidia	Improve exercise ability in patients with: (1) PAH; (2) Pulmonary hypertension associated with interstitial lung disease	Oral inhalation	May
atrasentan	Vanrafia	Novartis	Primary IgA nephropathy	Oral	April
nipocalimab-aahu	Imaavy	Janssen	Generalized myasthenia gravis in patients ≥ 12 years of age who are anti-AChR or anti-MuSK antibody positive	IV	April
diazoxide choline	Vykat XR	Soleno	Hyperphagia in Prader-Willi syndrome (≥ 4 years of age)	Oral	March
fitusiran	Qfitlia	Sanofi	Bleed prophylaxis in hemophilia A or B with or without inhibitors (≥ 12 years of age)	SC	March
tesamorelin F8 formulation	Egrifta WR	Theratechnologies	HIV lipodystrophy	SC	March
apomorphine HCl	Onapgo	Supernus	Advanced Parkinson's disease	SC (continuous infusion)	February
chenodiol	Ctexli	Mirum	Cerebrotendinous xanthomatosis	Oral	February

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
belimumab	Benlysta	GlaxoSmithKline	Autoinjector approved for pediatric patients ≥ 5 years of age with lupus nephritis	SC	June
dupilumab	Dupixent	Regeneron	Bullous pemphigoid	SC	June
emapalumab-lzsg	Gamifant	Novimmune	Expanded indication to include hemophagocytic lymphohistiocytosis/ macrophage activation syndrome in Still's disease (newborn and older)	IV	June
glecaprevir and pibrentasvir	Mavyret	Abbvie	Acute HCV infection (≥ 3 years of age)	Oral	June
antihemophilic factor (recombinant), PEGylated-aucl	Jivi	Bayer	Expanded indication (≥ 7 years of age) for hemophilia A	IV	May
mepolizumab	Nucala	GlaxoSmithKline	COPD with an eosinophilic phenotype	SC	May
ranibizumab	Susvimo	Genentech	Diabetic retinopathy	Intravitreal	May
dupilumab	Dupixent	Regeneron	Chronic spontaneous urticaria (≥ 12 years of age)	SC	April
inebilizumab-cdon	Uplizna	Amgen	IgG4-related disease	IV	April
osilodrostat	Isturisa	Recordati Rare Diseases	Expanded indication for endogenous hypercortisolemia in Cushing's syndrome	Oral	April
upadacitinib	Rinvoq	Abbvie	Giant cell arteritis	Oral	April
fluocinolone acetonide	Iluvien	Ani	Chronic non-infectious uveitis affecting the posterior segment of the eye	Intravitreal	March
furosemide	Furoscix	scPharmaceuticals	Edema in patients with CKD	SC (continuous infusion)	March
guselkumab	Tremfya	Janssen	Crohn's disease	IV, SC	March
iptacopan	Fabhalta	Novartis	Complement 3 glomerulopathy	Oral	March
nedosiran	Rivfloza	Novo Nordisk	Expanded indication (≥ 2 years of age) for primary hyperoxaluria type 1	SC	March
vutrisiran	Amvuttra	Alnylam	Transthyretin amyloid cardiomyopathy (ATTR-CM)	SC	March
eculizumab	Soliris	Alexion	Expanded indication (≥ 6 years of age) for generalized myasthenia gravis	IV	February
ranibizumab	Susvimo	Genentech	Diabetic macular edema	Intravitreal	February
esketamine	Spravato	Janssen	Monotherapy for treatment-resistant depression	Intranasal	January
mirikizumab-mrkz	Omvoh	Eli Lilly	Crohn's disease	IV, SC	January

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
mitomycin intravesical solution	Zusduri	Urogen	Recurrent low-grade intermediate-risk non-muscle invasive bladder cancer	Intravesical	June
taletrectinib	Ibtrozi	Nuvation Bio	Locally advanced or metastatic ROS1+ NSCLC	Oral	June
avutometinib; defactinib	Avmapki Fakzynja Co-Pack	Verastem	KRAS-mutated recurrent low-grade serous ovarian cancer	Oral	May
telisotuzumab vedotin-tllv	Emrelis	Abbvie	Locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpression	IV	May
penpulimab-kcqx	no trade name	Akeso	(1) Recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) in combination with cisplatin or carboplatin and gemcitabine; (2) Metastatic non-keratinizing NPC with progression after prior therapy	IV	April
mirdametinib	Gomekli	SpringWorks	Neurofibromatosis type 1-associated plexiform neurofibromas (≥ 2 years of age)	Oral	February
nilotinib d-tartrate	no trade name	Cipla	Newly diagnosed Ph+ CML in chronic phase (CP); (2) CP and accelerated phase Ph+ CML resistant to imatinib	Oral	February
vimseltinib	Romvimza	Deciphera	Symptomatic tenosynovial giant cell tumor	Oral	February
datopotamab deruxtecan-dlnk	Datroway	Daiichi Sankyo	Unresectable or metastatic HR+, HER2- (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer	IV	January
treosulfan	Grafapex	Medexus	Preparative regimen for allogeneic HSCT in combination with fludarabine for patients with AML or MDS (≥ 1 year of age )	IV	January

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
darolutamide	Nubeqa	Bayer	Metastatic castration-sensitive prostate cancer as a single agent	Oral	June
datopotamab deruxtecan-dlnk	Datroway	Daiichi Sankyo	Locally advanced or metastatic EGFR-mutated NSCLC	IV	June
pembrolizumab	Keytruda	Merck Sharp and Dohme	Resectable locally advanced head and neck squamous cell carcinoma with tumors expressing PD-L1	IV	June
tafasitamab-cxix	Monjuvi	Incyte	R/R follicular lymphoma in combination with lenalidomide and rituximab	IV	June
belzutifan	Welireg	Merck Sharp and Dohme	Locally advanced, unresectable or metastatic pheochromocytoma or paraganglioma (≥ 12 years of age)	Oral	May
retifanlimab-dlwr	Zynyz	Incyte	(1) Locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) in combination with carboplatin and paclitaxel; (2) Locally recurrent or metastatic SCAC with disease progression as a single agent	IV	May
ipilimumab	Yervoy	Bristol-Myers Squibb	Indication for MSI-H or dMMR CRC in combination with Opdivo expanded to include treatment-naïve patients (≥ 12 years of age)	IV	April
ipilimumab	Yervoy	Bristol-Myers Squibb	Indication for unresectable or metastatic HCC in combination with Opdivo expanded to include treatment-naïve patients	IV	April
nivolumab	Opdivo	Bristol-Myers Squibb	Indication for MSI-H or dMMR CRC in combination with Yervoy expanded to include treatment-naïve patients (≥ 12 years of age)	IV	April
nivolumab	Opdivo	Bristol-Myers Squibb	Indication for unresectable or metastatic HCC in combination with Yervoy expanded to include treatment-naïve patients	IV	April
palbociclib	Ibrance	Pfizer	PIK3CA-mutated, HR+, HER2- locally advanced or metastatic breast cancer in combination with Itovebi and Faslodex	Oral	April
cabozantinib	Cabometyx	Exelixis	Pancreatic and extra-pancreatic neuroendocrine tumors (≥ 12 years of age)	Oral	March
durvalumab	Imfinzi	AstraZeneca	Neoadjuvant and adjuvant treatment for muscle invasive bladder cancer	IV	March
tislelizumab-jsgr	Tevimbra	BeiGene	First line for advanced esophageal squamous cell carcinoma in combination with platinum-containing chemotherapy	IV	March
brentuximab vedotin	Adcetris	Seagen	R/R large B-cell lymphoma in combination with lenalidomide and rituximab	IV	February
acalabrutinib	Calquence	AstraZeneca	Untreated mantle cell lymphoma in combination with bendamustine and rituximab	Oral	January
fam-trastuzumab deruxtecan-nxki	Enhertu	Daiichi Sankyo	Unresectable or metastatic HR+, HER2- (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer	IV	January
panitumumab	Vectibix	Amgen	KRAS G12C-mutated metastatic colorectal cancer in combination with sotorasib	IV	January
sotorasib	Lumakras	Amgen	KRAS G12C-mutated metastatic colorectal cancer in combination with panitumumab	Oral	January

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
lisdexamfetamine dimesylate oral solution	Arynta	Azurity	(1) ADHD (≥ 6 years of age); (2) Binge eating disorder	Oral	June
telmisartan/ amlodipine/ indapamide	Widaplik	George Medicines	HTN	Oral	June
acoltremon	Tryptyr	Alcon	Dry eye disease	Ophthalmic	May
dihydroergotamine injection	Brekiya	Amneal	Acute treatment of migraine and cluster headaches	SC	May
aripiprazole oral film	Mezofy	CMG	Schizophrenia (≥ 13 years of age)	Oral	April
dihydroergotamine nasal powder	Atzumi	Satsuma	Acute treatment of migraine	Intranasal	April
metoprolol tartrate oral solution	Lopressor	Validus	(1) HTN; (2) Long-term treatment of angina pectoris; (3) Hemodynamically stable patients with MI in conjunction with IV metoprolol	Oral	April
chlorthalidone	Hemiclor	PRM	HTN	Oral	March
gepotidacin	Blujepa	GSK	Uncomplicated UTI (females ≥ 12 years of age)	Oral	March
losartan oral suspension	Arbli	Scienture	(1) HTN (> 6 years of age); (2) Risk reduction in patients with HTN and LVH; (3) Diabetic nephropathy	Oral	March
aztreonam / avibactam	Emblaveo	Abbvie	Complicated intra-abdominal infections in combination with metronidazole	IV	February
copper intrauterine system	Miudella	Sebela Women's Health	Pregnancy prevention for up to 3 years	Intrauterine	February
hydrochlorothiazide oral suspension	Inzirqo	Ani	Adults and pediatric patients with (1) HTN; (2) edema associated with CHF, hepatic cirrhosis and renal disease	Oral	January
meloxicam / rizatriptan	Symbravo	Axsome	Acute treatment of migraine	Oral	January
sitagliptin oral solution	Brynovin	Azurity	T2DM	Oral	January
suzetrigine	Journavx	Vertex	Moderate to severe acute pain	Oral	January

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
cobicistat	Tybost	Gilead	Indication for HIV-1 expanded to include: (1) pediatric patients weighing ≥ 14 kg to < 35 kg in combination with atazanavir and other ARVs except for tenofovir alafenamide; (2) pediatric patients weighing ≥ 15 kg to < 40 kg in combination with darunavir and other ARVs	Oral	June
emtricitabine/ tenofovir alafenamide fumarate	Descovy	Gilead	Indication for HIV-1 expanded to include pediatric patients weighing ≥ 14 kg to < 35 kg in combination with other ARVs, including darunavir and cobicistat, but not other protease inhibitors that require a CYP3A inhibitor	Oral	June
roflumilast 0.3% foam	Zoryve	Arcutis	Plaque psoriasis of the scalp and body (≥ 12 years of age)	Topical	May
apixaban	Eliquis	Bristol-Myers Squibb	Expanded indication (pediatric patients from birth) for treatment of VTE and risk reduction for recurrent VTE	Oral	April
dexamethasone ophthalmic insert	Dextenza	Ocular Therapeutix	Indications expanded to include pediatric patients: (1) ocular inflammation and pain following ophthalmic surgery; (2) allergic conjunctivitis (≥ 2 years of age)	Ophthalmic insert	April
diazepam nasal spray	Valtoco	Neurelis	Expanded indication (≥ 2 years of age) for epilepsy	Intranasal	April
palonosetron	Posfrea	Avyxa	Expanded indication (1 month to < 17 years of age) for chemotherapy-induced nausea and vomiting	IV	April
tedizolid	Sivextro	Cubist	Indication for ABSSSI expanded to include (1) patients < 12 years of age weighing ≥ 35 kg (oral); (2) patients ≥ 26 weeks gestational age and weighing ≥ 1 kg (IV)	IV, Oral	April
darunavir / cobicistat	Prezcobix	Janssen	Expanded indication (≥ 25 kg to < 40 kg) for HIV-1 infection	Oral	March
epinephrine nasal spray	Neffy	ARS	Expanded indication (≥ 4 years of age weighing ≥ 15 kg) for type I allergic reactions	Intranasal	March
glucagon nasal powder	Baqsimi	Amphastar	Expanded indication (1 to 3 years of age) for severe hypoglycemia	Intranasal	March
emtricitabine / rilpivirine / tenofovir alafenamide	Odefsey	Gilead	Expanded indication (≥ 25 kg to < 35 kg) for HIV-1 infection	Oral	February
house dust mite (Dermatophagoides farinae & Dermatophagoides pteronyssinus) allergen extract	Odactra	ALK-Abello	Expanded indication (5 to 11 years of age) for house dust mite-induced allergic rhinitis	Oral	February
moxidectin	no trade name	Medicines Development for Global Health	Expanded indication (4 to < 12 years of age) for onchocerciasis	Oral	February
semaglutide	Ozempic	Novo Nordisk	Reduce risk of worsening kidney disease and CV death in patients with T2DM and CKD	SC	January

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
COVID-19 vaccine, adjuvanted	Nuvaxovid	Novavax	Active immunization to prevent COVID-19 in: (1) adults ≥ 65 years of age; (2) high-risk patients 12 to 64 years of age	IM	May
COVID-19 vaccine, mRNA	mNexspike	Moderna	Active immunization to prevent COVID-19 in: (1) adults ≥ 65 years of age; (2) high-risk patients 12 to 64 years of age	IM	May
smallpox and mpox vaccine, live, non-replicating, freeze-dried formulation	Jynneos	Bavarian Nordic	Prevention of smallpox and mpox disease	IM	March
chikungunya vaccine, recombinant	Vimkunya	Bavarian Nordic	Prevention of chikungunya virus disease (≥ 12 years of age)	IM	February
meningococcal groups A, B, C, W and Y vaccine	Penmenvy	GSK	Prevention of disease caused by Neisseria meningitidis serogroups A, B, C, W and Y (10 through 25 years of age)	IM	February

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
RSV vaccine	mResvia	Moderna	Indication for prevention of LRTD caused by RSV expanded to include patients 18 through 59 years of age who are at increased risk	IM	June
meningococcal (groups A, C, Y, W) conjugate vaccine	MenQuadfi	Sanofi Pasteur	Indication for prevention of invasive meningococcal disease expanded to include patients 6 weeks to 23 months of age	IM	May

Generic name	Brand name	Reference product	Manufacturer	Indication(s)	Route of administration	Month approved*
ustekinumab-hmny	Starjemza (interchangeable)	Stelara	Bio-Thera / Hikma	Autoimmune disorders	IV, SC	May
bevacizumab-nwgd	Jobevne	Avastin	Biocon	Select patients with CRC, NSCLC, glioblastoma, RCC, cervical cancer and epithelial ovarian, fallopian tube or primary peritoneal cancer	IV	April
denosumab-bnht	Bomyntra	Xgeva	Fresenius Kabi	Bone health	SC	March
denosumab-bnht	Conexxence	Prolia	Fresenius Kabi	Bone health	SC	March
omalizumab-igec	Omlyclo (interchangeable)	Xolair	Celltrion	(1) Asthma; (2) Chronic rhinosinusitis with nasal polyps; (3) IgE-mediated food allergies; (4) Chronic spontaneous urticaria	SC	March
denosumab-bmwo	Osenvelt	Xgeva	Celltrion	Bone health	SC	February
denosumab-bmwo	Stoboclo	Prolia	Celltrion	Bone health	SC	February
denosumab-dssb	Ospomyv	Prolia	Samsung Bioepis	Bone health	SC	February
denosumab-dssb	Xbryk	Xgeva	Samsung Bioepis	Bone health	SC	February
insulin aspart-szjj	Merilog, Merilog SoloStar	Novolog	Sanofi-Aventis	Diabetes mellitus	SC	February
tocilizumab-anoh	Avtozma	Actemra	Celltrion	Autoimmune disorders and COVID-19	IV, SC	January

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
rituximab-abbs	Truxima	Teva	Pemphigus vulgaris	IV	June
rituximab-arrx	Riabni	Amgen	Pemphigus vulgaris	IV	June
rituximab-pvvr	Ruxience	Pfizer	Pemphigus vulgaris	IV	June
filgrastim-ayow	Releuko	Kashiv Biosciences	(1) Autologous hematopoietic progenitor cell mobilization for leukapheresis collection; (2) Hematopoietic syndrome of acute radiation syndrome	SC	April
pegfilgrastim-pbbk	Fylnetra	Kashiv Biosciences	Hematopoietic subsyndrome of acute radiation syndrome	SC	April
tocilizumab-aazg	Tyenne	Fresenius Kabi	(1) Hospitalized adults with COVID-19; (2) CAR T cell-induced CRS (≥ 2 years of age)	IV	February

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
prademagene zamikeracel	Zevaskyn	Abeona	Recessive dystrophic epidermolysis bullosa	Surgical - Topical	April
revakinagene taroretcel-lwey	Encelto	Neurotech	Macular telangiectasia type 2	Intravitreal	March

None

AAVRh74var adeno-associated virus serotype Rh74var
ABSSSI acute bacterial skin and skin structure infections
AchR acetylcholine receptor
ADHD attention deficit hyperactivity disorder
ALK anaplastic lymphoma kinase
ALK+ anaplastic lymphoma kinase-positive
ALL acute lymphoblastic leukemia
AML acute myeloid leukemia
AQP4 anti-aquaporin-4
ARV antiretroviral
BPH benign prostatic hyperplasia
BRAF v-raf murine sarcoma viral oncogene homolog B1
CAR chimeric antigen receptor
CD19+ cluster of differentiate 19-positive
CD22+ cluster of differentiate 22-positive
CFTR cystic fibrosis transmembrane conductance regulator
CHF congestive heart failure
CIDP chronic inflammatory demyelinating polyneuropathy
CKD chronic kidney disease
CML chronic myeloid leukemia
COPD chronic obstructive pulmonary disease
COVID-19 coronavirus disease 2019
CRC colorectal cancer
CRS cytokine release syndrome
CV cardiovascular
CVD cardiovascular disease
CYP cytochrome P450
DMD Duchenne muscular dystrophy
dMMR deficient mismatch repair
EGFR epidermal growth factor receptor
ER extended release
ERC enhanced removal capability
FGFR3 fibroblast growth factor receptor 3
GERD gastroesophageal reflux disease
GVHD graft versus host disease
HCC hepatocellular carcinoma
HCI hydrochloride
HER2 human epidermal growth factor receptor 2
HER2+ human epidermal growth factor receptor 2-positive
HER2- human epidermal growth factor receptor 2-negative
HF heart failure
HIV-1 human immunodeficiency virus type-1
HR hormone receptor
HR+ hormone receptor-positive
HSCT hematopoietic stem cell transplant
HTN hypertension
Ig immunoglobulin
IDH isocitrate dehydrogenase
IHC immunohistochemistry
IM intramuscular
ISH in situ hybridization
IV intravenous
KMT2A lysine methyltransferase 2A gene
KRAS Kirsten rat sarcoma virus
LEPR leptin receptor
LRTD lower respiratory tract disease
LVH left ventricular hypertrophy
MDS myelodysplastic syndrome
mFOLFOX6 fluorouracil, leucovorin, oxaliplatin
MI myocardial infarction
MSI-H microsatellite instability-high
MuSK muscle-specific tyrosine kinase
NRG1+ neuregulin 1-positive
NSCLC non-small cell lung cancer
NTRK neurotrophic tyrosine receptor kinase
ODT orally disintegrating tablet
PAH pulmonary arterial hypertension
PCSK1 proprotein convertase subtilisin/kexin type 1
PD-L1+ programmed death-ligand 1-positive
Ph+ Philadelphia chromosome-positive
Ph- Philadelphia chromosome-negative
PIK3CA phosphatidylinositol-3-kinase catalytic subunit alpha
POMC pro-opiomelanocortin
PrEP pre-exposure prophylaxis
R/R relapsed or refractory
RET rearranged during transfection
RNA ribonucleic acid
RSV respiratory syncytial virus
SC subcutaneous
SCLC small cell lung cancer
sJIA systemic juvenile idiopathic arthritis
T2DM type 2 diabetes mellitus
UTI urinary tract infection
VEGF vascular endothelial growth factor
VTE venous thromboembolism
XR extended release

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