Johnson & Johnson files two supplemental BLAs for Tremfya (guselkumab) for treating certain children with moderate-to-severe plaque psoriasis and acti...
FDA issues Applied Therapeutics a complete response letter on its NDA for govorestat and its use for treating classic galactosemia.
FDA approves a Mentor Worldwide PMA for its MemoryGel Enhance Breast Implants for reconstruction breast surgery in post-mastectomy women.
Baxter recalls its AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposure to hazardous chemi...
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Federal Register notice: FDA makes available a draft guidance entitled Recommended Follow-up Testing for an Ames-Positive Drug (Active Ingredient) or ...
Federal Register notice: FDA makes available a draft guidance entitled Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development ...
