Submitted supplemental drugs Phase 3 supplemental drugs arimoclomol oral Name Manufacturer Clinical Use Dosage Form Development Status camrelizumab Jiangsu Hengrui HCC (unresectable, 1st-line, in...

Name Manufacturer Clinical Use Dosage Form Development Status FDA Decision adalimumab-bwwd 40 mg/0.4 mL (Hadlima™) (biosimilar to Abbvie’s Humira®) Organon RA; AS; PSO; PsA; JIA; CD; UC; HS;...

Submitted supplemental drugs brensocatib oral Manufacturer: PTC Proposed indications Friedreich's ataxia (FA) Clinical overview Mechanism of action Vatiquinone is a first-in-class selective...

Manufacturer: Abeona Proposed indications Recessive dystrophic epidermolysis bullosa (RDEB) Clinical overview Mechanism of action Prademagene zamikeracel (pz-cel) is an autologous, collagen type...