Federal Register notice: FDA announces a 10/7 Science Board Advisory Committee meeting that will hear an update from the new Alternative Methods Subco...
Two stakeholders call on FDA to make major changes to a draft guidance on the REMS logic model that is intended to link program design with assessment...
The drug development consulting firm Rahaa asks FDA to require stability studies under refrigerated conditions for generic versions of prednisolone op...
FDA gives accelerated approval to Gileads Livdelzi to treat some cases of primary biliary cholangitis.
After reporting preliminary positive results from a Phase 2 clinical trial studying VP-315 in basal cell carcinoma patients, Verrica Pharmaceuticals s...
FDA approves Incytes Niktimvo for some adult and pediatric host-versus-graft treatments.
FDA and the American Society of Clinical Oncology announce a 10/1 joint workshop entitled Measuring Toxicity in Reproductive Organs During Oncology Dr...