FDA commissioner Marty Makary hands in his resignation after a week of mounting speculation that the Trump Administration was preparing to remove him....
Ipsen withdraws its cancer drug Tazverik (tazemetostat) from the U.S. market after new clinical trial data showed an increased risk of serious seconda...
Stakeholders ask FDA to clarify its draft guidance on responses to an FDA-483.
An FDA Federal Register notice requests information from drug developers and academic investigators to support a pilot project focused on novel biomar...
FDA warns Indias Ashirwad Hospital Center and clinical investigator Mukesh Chandre about failing to obtain informed consent for a bioequivalence study...
A March inspection of SCA Pharmaceuticals cites multiple manufacturing and contamination-control deficiencies at its outsourcing facility in Windsor, ...
FDA warns Israels Naveh Pharma and Atlanta, GA-based Bigdam about selling unapproved new drugs that are adulterated by CGMP violations.
An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.
