FDA warns Noblesville, IN-based Ambu, Inc., that it is illegally distributing an unapproved medical device.
FDA lifts a clinical hold against a Fulcrum Therapeutics IND for FTX-6058 for the potential treatment of sickle-cell disease.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug developers.
Metacel says FDA must require sponsors of generic Ozobax to perform and submit the same flavoring safety data that Metacel was required to submit.
South Carolina GOP Rep. Jeff Duncan says FDA should retain the Office of Dietary Supplement Programs as a freestanding entity rather than merging it i...
FDA approves Pfizers RSV vaccine Abrysvo for use in pregnant women to protect infants from birth to 6 months of age.
FDA clears a Nurami Medical 510(k) for its ArtiFascia Dura Substitute, a resorbable dura mater repair graft.
FDA commissioner Robert Califf tells an Alliance for a Stronger FDA webinar that ongoing drug shortages are a huge national security risk and better i...
