The FDA has approved a single-dose, preservative-free formulation of Makena (hydroxyprogesterone caproate injection) from AMAG Pharmaceuticals. Makena is the only...
AMAG Pharmaceuticals announced topline results from PROLONG, a randomized, double-blinded, placebo-controlled clinical trial evaluating Makena (progestin) in patients with a...
AMAG Pharmaceuticals, Inc. announced the FDA Bone, Reproductive and Urologic Drugs Advisory Committee met to better understand and interpret the...
The FDA had reached a final decision to fully withdraw approval of preterm-birth drug Makena and its generics, a full 12 years after the treatment appeared on the market.
Covis Pharma Group announced it has submitted a response to the Presiding Officer’s report summarizing the October 17-19, 2022 public hearing and providing recommendations on the Center for Drug Evaluation and Research’s (CDER) proposal to withdrawal approval for Makena (hydroxyprogesterone caproate injection), the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth.
AMAG Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to acquire Lumara Health Inc., a privately-held pharmaceutical...