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The FDA said it could not approve AbbVie’s new drug application (NDA) for ABBV-951 (foslevodopa/foscarbidopa), an investigational therapy for advanced Parkinson’s disease, because of concerns about the delivery device. Read More
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.