USFDA Archives - Page 18 of 36 - Express Pharma

FDA accepts NDA and grants priority review of Zuranolone from Sage Therapeutics, Biogen

Fix quality issues, the rest will fall in place

Stelis Biopharma’s facility receives EIR from USFDA

USFDA pulls up Sun Pharma for lapses in Halol plant

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