FDA publishes a guidance to help sponsors planning to use circulating tumor DNA as a biomarker in some cancer trials.
FDA releases the form FDA-483 with four observations from a 2023 inspection at the Monza, Italy-based Patheon Italia sterile drug manufacturer.
Federal Register notice: FDA makes available a draft guidance entitled Recommended Follow-up Testing for an Ames-Positive Drug (Active Ingredient) or ...
Federal Register notice: FDA makes available a draft guidance entitled Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development ...
Federal Register notice: FDA renews its Oncologic Drugs Advisory Committee for an additional two years.
FDA identifies eight broad areas for the GDUFA FY 2025 science and research priorities.
PTC Therapeutics says its utreloxastat failed to meet the primary endpoint in a Phase 2 ALS study and development will not continue.
FDA issues an alert about serious adverse event reports associated with Bluebird Bios Skysona (elivaldogene autotemcel), a gene therapy for treating b...
