Federal Register notice: FDA revokes two emergency use authorizations one issued to Becton Dickinson and the other to Talis Biomedical.
Federal Register notice: FDA makes available a draft guidance entitled Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-C...
FDA accepts for review a Pfizer NDA for baldness drug ritlecitinib for treating adults and adolescents with alopecia areata.
Federal Register notice: FDA makes available a final guidance entitled Submitting Documents Using Real-World Data and Real-World Evidence to FDA for D...
FDA publishes a final guidance on identifying real-world data and real-world evidence submitted in INDs, NDAs, and BLAs.
FDA denies a petition seeking a Boxed Warning for excimer lasers used in LASIK procedures.
Sklip Inc. receives IRB approval to clinically test its Sklip artificial intelligence skin cancer triage system with patients in home settings.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Neurocrine Biosciences Orilissa (elagolix sodiu...
