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FDA releases the form FDA-483 with four observations from a 2023 inspection at the Monza, Italy-based Patheon Italia sterile drug ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Recommended Follow-up Testing for an Ames-Positive Drug (Ac...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Assessment of Ovarian Toxicity in Premenopausal Adults Duri...[ Price : $8.95]
Federal Register notice: FDA renews its Oncologic Drugs Advisory Committee for an additional two years.[ Price : $8.95]
FDA identifies eight broad areas for the GDUFA FY 2025 science and research priorities.[ Price : $8.95]
PTC Therapeutics says its utreloxastat failed to meet the primary endpoint in a Phase 2 ALS study and development will not continu...[ Price : $8.95]
FDA issues an alert about serious adverse event reports associated with Bluebird Bios Skysona (elivaldogene autotemcel), a gene th...[ Price : $8.95]
FDA extends by three months its review of a Soleno Therapeutics NDA for DCCR (diazoxide choline) extended-release tablets for trea...