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Johnson & Johnson files two supplemental BLAs for Tremfya (guselkumab) for treating certain children with moderate-to-severe plaqu...[ Price : $8.95]
FDA issues Applied Therapeutics a complete response letter on its NDA for govorestat and its use for treating classic galactosemia...[ Price : $8.95]
FDA approves a Mentor Worldwide PMA for its MemoryGel Enhance Breast Implants for reconstruction breast surgery in post-mastectomy...[ Price : $8.95]
Baxter recalls its AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposur...[ Price : $8.95]
FDA publishes a guidance to help sponsors planning to use circulating tumor DNA as a biomarker in some cancer trials.[ Price : $8.95]
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Federal Register notice: FDA makes available a draft guidance entitled Recommended Follow-up Testing for an Ames-Positive Drug (Ac...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Assessment of Ovarian Toxicity in Premenopausal Adults Duri...