FDA approves a Johnson & Johnson supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemotherapy for treating adul...
Federal Register notice: FDA withdraws approval of nine no-longer-marketed ANDAs from multiple applicants.
Federal Register notice: FDA seeks comments on an information collection revision entitled Postmarketing Adverse Experience Reporting.
Smiths Medical recalls (Class 1) its ParaPAC plus P300 and P310 ventilators due to the possibility that patient outlet connectors may become loose or ...
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FDA publishes a draft guidance with recommended chemical analyses for medical device biocompatibility assessment.
