CDER posts its Office of Compliance Annual Report for fiscal year 2022.
Datascope/Getinge recalls Cardiosave Hybrid IABPs and Rescue IABPs because the coiled cable connecting the display and base on some units may fail, ca...
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.
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.
FDA publishes an International Pharmaceutical Regulators Program reflection paper addressing general considerations for using raw materials in the man...
