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accelerated approval
Pharma
CBER chief Peter Marks resigns from FDA
In his resignation letter, Peter Marks, M.D., Ph.D., blasted the promotion of vaccine disinformation under new HHS Secretary Robert F. Kennedy Jr.
Fraiser Kansteiner
Mar 31, 2025 10:50am
OIG says FDA accelerated approval program needs adjustments
Jan 16, 2025 3:45pm
FDA looks to clarify follow-up testing mandate for speedy nods
Jan 6, 2025 3:36pm
Merus' Bizengri wins FDA nod as 1st drug to target NRG1+ cancers
Dec 4, 2024 6:55pm
FDA raises safety flags ahead of adcomm for AZ's Andexxa
Nov 20, 2024 8:33am
FDA shoots down Intercept's bid for full approval of Ocaliva
Nov 12, 2024 2:12pm
