USFDA Archives - Page 3 of 21 - Express Pharma

USFDA issues CRL for proposed biosimilar Insulin-R: Biocon

USFDA grants priority review to Roche’s glofitamab

USFDA accepts AstraZeneca’s BLA for nirsevimab to prevent RSV lower respiratory tract disease

USFDA allows abortion pills to be sold at retail pharmacies

USFDA grants appeal for Ardelyx’s kidney disease drug

Alembic Pharma gets USFDA nod for Fulvestrant injection, 250 mg/5 mL per single-dose syringe

USFDA issues import alert on Glenmark Pharma’s Baddi plant

Zydus gets USFDA nod for Prochlorperazine Maleate Tablets

Aleor Dermaceuticals gets USFDA approval for Diclofenac Sodium Topical Gel

Sun Pharma, Glenmark recall drugs in US due to manufacturing deviations