FDA releases the 19-page form FDA-483 with seven observations from an inspection at the Lupin drug manufacturing facility in Verna, Salcette, Goa, Ind...
A new JAMA Health Forum analysis examines FDAs shift in how it seeks outside scientific advice while shunning advisory committee meetings, raising leg...
FDA grants Pilatus Biosciences a fast-track designation for its lead drug candidate, PLT012, for treating hepatocellular carcinoma.
Minutes from a 1/21 GDUFA 4 reauthorization negotiating session show back and forth between FDA and industry participants on several topics.
FDA warns Dr. Bertrand Cole in Portsmouth, NH, about failing to conduct a clinical study according to the investigational plan.
FDA reverses course and agrees to review Modernas seasonal influenza mRNA vaccine after previously refusing to file the BLA.
The Sedgwick Recall Index year-end report for 2025 finds that the number of medical device recalls dropped compared to 2024, while drug recalls were s...
An FDA perspective in the New England Journal of Medicine outlines the agencys move away from requiring two pivotal trials for drug approval.
