AMAG Pharmaceuticals Inc.

The outcome of the October 2022 public hearing on the FDA Center for Drug Evaluation and Research’s proposal to withdraw Covis Pharma ’s Makena was negatively influenced by hearing officer Celia Witt

Covis Pharma said it will “voluntarily withdraw” the preterm birth prevention drug Makena (hydroxyprogesterone caproate injection, also known as 17-OHPC or 17-P) from the US market, a decision that f

The Makena withdrawal process will provide many lessons for sponsors and regulators alike as efforts continue to optimize the US Food & Drug Administration’s Accelerated Approval pathway. The lopsided

Covis Pharma is hoping to convince a US Food and Drug Administration advisory committee – and senior agency officials – that its preterm birth prevention drug Makena (hydroxyprogesterone caproate inj