FDA clears an Overjet 510(k) to expand the use of its artificial intelligence technology for predicting tooth decay in younger patients.
FDA approves a Pfizer and OPKO Health BLA for Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treating pediatric pa...
FDA sends Eton Pharmaceuticals a second complete response letter on its NDA for dehydrated alcohol injection for treating methanol poisoning.
Federal Register notice: FDA makes available a draft guidance entitled Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Co...
FDA releases the form FDA-483 with four observations issued following an inspection at the Prisma Health outsourcing facility in Simpsonville, SC.
Federal Register notice: FDA makes available a final guidance entitled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DT...
FDA issues an Import Alert against all drugs from Chinas Chengdu KeCheng Fine Chemicals and a Warning Letter about its continuing failure to respond t...
Eli Lilly says new Phase 2 data on weight-loss candidate retatrutide met primary and secondary endpoints.
