FDA accepts for review an Ipsen resubmitted NDA for palovarotene as a potential treatment for fibrodysplasia ossificans progressive.
FDA publishes an updated question-and-answer guidance on the definition and regulation of medical foods.
Federal Register notice: FDA posts a final guidance entitled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Unde...
Federal Register notice: FDA posts a draft guidance with information for sponsors who are developing certain local anesthetic drug products to produce...
Federal Register notice: FDA makes available a final guidance entitled The Use of Published Literature in Support of New Animal Drug Approvals.
FDA approves a Telix Pharmaceuticals supplemental NDA for Illuccix and its use in selecting prostate cancer patients for whom Novartis Pluvicto is ind...
FDA clears the BD Vaginal Panel running on the BD COR System to detect the three most common causes of vaginitis.
GlaxoSmithKline says its meningococcal MenABCWY vaccine candidate met all 11 primary endpoints in a pivotal Phase 3 trial.
