FDA posts three medical device-related draft guidances about the agencys Accreditation Scheme for Conformity Assessment Program.
FDA approves a Sanofi-Aventis supplemental BLA for Sarclisa (isatuximab-irfc) for use with bortezomib, lenalidomide, and dexamethasone for adults with...
Federal Register notice: FDA proposes to revoke the routdated egulations entitled Mutual Recognition of Pharmaceutical Good Manufacturing Practice Rep...
FDA approves a Johnson & Johnson supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemotherapy for treating adul...
Vanda criticizes FDA for failing to approve its NDA for tradipitant to treat gastroparesis.
Federal Register notice: FDA announces a 10/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations...
Bionpharma recalls (Class 1) a single Batch (#2310083) of atovaquone oral suspension due to contamination with Cohnella bacteria.
FDA publishes a draft guidance with recommended chemical analyses for medical device biocompatibility assessment.
