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Makena
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
AMAG loses insurance claim tied to Pfizer manufacturing hitch
Aug 21, 2024 12:30pm
EU regulator calls for withdrawal of certain preterm birth drugs
May 17, 2024 10:37am
FDA pulls the plug on Covis' troubled preterm birth med Makena
Apr 7, 2023 8:05am
'The Top Line': AI and machine learning, plus the headlines
Mar 10, 2023 6:00am
Covis agrees to sideline Makena, the lone drug for preterm birth
Mar 8, 2023 10:46am
