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accelerated approval
Pharma
OIG says FDA accelerated approval program needs adjustments
The OIG recommended tweaks to the FDA’s accelerated approval pathway but concluded that the controversial nod for Biogen's Aduhelm was an outlier.
Kevin Dunleavy
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
Jazz's almost-withdrawn lung cancer drug shows life
Oct 15, 2024 10:15am
