FDA releases the form FDA-483 with three observations issued following an inspection at the Sugar Land, TX-based QuVa Pharma outsourcing facility.
CDER director Patrizia Cavazzoni tells the Alliance for a Stronger FDA that the Center is in growth mode after the user fee reauthorization on 9/30/20...
FDA approves a Synapse Biomedical PMA for the NeuRx Diaphragm Pacing System for use in patients with spinal cord injuries who rely on mechanical venti...
FDA outlines research into potential pharmacodynamic biomarkers for biosimilar development.
Federal Register notice: FDA establishes a docket to obtain information and comments to help assess whether in-home disposal products can be expected ...
CBER director Peter Marks says Covid-19 vaccine makers will be given advice in June on the next booster vaccine composition for fall injections.
Phathom Pharmaceuticals says it will resubmit an NDA for vonoprazan for treating erosive esophagitis, and a post-approval supplement for Voquezna Trip...
FDA accepts for review two Pfizer Supplemental NDAs for Braftovi (encorafenib) and Mektovi (binimetinib) and their use in patients with metastatic non...
