FDA
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
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Pharma 2025 GTM Trends Advancing Access and Affordability in a Challenging Market

Pharma 2025 GTM Trends

Jan 13, 2025 8:00am
Judge banging gavel on stack of money

Gilead, US government resolve long-running HIV patent dispute

Jan 16, 2025 10:48am
Whats Ahead for Patient Support Services in 2025

What’s Ahead for Patient Support Services in 2025?

Jan 13, 2025 8:00am
approval drug approval FDA EMA

Regulatory tracker: Lilly's Omvoh scores Crohn's nod from FDA

Jan 16, 2025 10:25am
kite

Gilead's Kite taps Amgen alum as new global commercial head

Jan 16, 2025 10:14am
Manufacturing News

Atara, Pierre Fabre hit a hurdle with Ebvallo in the US

Jan 16, 2025 9:36am

Argentina biotech to produce Pfizer's Prevnar 20 in access push

Jan 16, 2025 8:38am

Lyndra enlists Thermo Fisher for research, manufacturing support

Jan 15, 2025 3:36pm

JPM25: CDMO giant Samsung Bio weighs plan to build 6th plant

Jan 15, 2025 9:46am