Unresolved questions about the clinical efficacy of a hypotension drug that received accelerated approval 23 years ago highlight the challenges the US Food and Drug Administration and its external advisors will face in weighing whether AMAG Pharmaceuticals Inc.'s preterm birth drug Makena should remain on the market despite failure to confirm clinical benefit.
On 29 October, the FDA will convene its Bone, Reproductive and Urologic Drugs Advisory Committee to consider the continued availability...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?