FDA warns Australias Antaria Pty. Ltd. about CGMP deviations in its production of active pharmaceutical ingredients.
A Congressional Research Service paper points to possible legislation Congress may want to consider to clarify how FDA is to use confidential informat...
A KFF Health News report carried online by NBC says 10 members of an FDA advisory committee evaluating an Abbott cardiac device had received money fro...
FDA approves ViiV Healthcares Dovato (dolutegravir/lamivudine) for treating HIV-1 infection in adolescents with no antiretroviral treatment history or...
FDA accepts for review a Stealth BioTherapeutics NDA for elamipretide for treating Barth syndrome.
FDA clears a Spirair 510(k) for its SeptAlign system for treating nasal septal deviation.
FDA approves a supplemental BLA submitted by Janssen for Carvykti (ciltacabtagene autoleucel) to treat adults with relapsed or refractory myeloma who ...
FDA sends Supernus Pharmaceuticals a second complete response letter on its NDA resubmission for the companys apomorphine infusion device (SPN-830) fo...
