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Covis Pharma is willing to withdraw from the market its premature birth drug Makena (hydroxyprogesterone caproate injection), the company wrote in a letter to the FDA that requests the agency allow it an “orderly wind-down” period rather than an abrupt end to the drug’s availability.
Responding to FDA Commissioner Robert Califf’s recent remarks regarding the value of advisory committee (AdComm) votes, two major industry advocates offered slightly different takes on the question.
The FDA has granted priority review to Eisai’s and Biogen’s supplemental biologics license application (sBLA) for their Alzheimer’s treatment candidate Leqembi (lecanemab-irmb), supporting the biologic’s conversion from Accelerated Approval (AA) to traditional approval. Read More
The FDA has said no to Cytokinetics’ new drug application (NDA) for omecamtiv mecarbil, an investigational treatment for heart failure with reduced ejection fraction (HFrEF). Read More
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