October’s advisory committee lineup

FDA will hold four advisory committee meetings in October to discuss troubled premature birth drug Makena, as well as GSK’s daprodustat, Y-mAbs’ omburtamab and Ipsen’s palovarotene.

The Obstetrics, Reproductive and Urologic Drugs Advisory Committee will convene a three-day hearing Oct. 17-19 to discuss whether Makena hydroxyprogesterone caproate from Covis Pharma S.a.r.l. should remain on the market. Depending on the outcome, Makena could mark the second time FDA has used its authority to pull a therapy from the market that had been granted accelerated approval. ...