Akebia Therapeutics says it plans to resubmit an NDA to FDA for vadadustat to treat anemia due to chronic kidney disease.
FDA grants Nectero Medical a fast track designation for its Endovascular Aneurysm Stabilization Treatment combination product for treating infrarenal ...
FDA clears a Paragonix Technologies 510(k) for its next-generation donor lung preservation system, BAROguard.
Oregon State University says two research studies show that more drug approval transparency is needed.
Federal Register notice: FDA announces a 10/5 Vaccines and Related Biological Products Advisory Committee meeting to discuss the 2024 flu virus strain...
FDA grants Taysha Gene Therapies a fast track designation for TSHA-102, an intrathecally delivered AAV9 gene transfer therapy for treating Rett syndro...
FDA approves a Sandoz BLA for Tyruko (natalizumab-sztn), the first biosimilar to Biogens Tysabri (natalizumab) injection for treating adults with rela...
FDA says its Endocrinologic and Metabolic Drugs Advisory Committee will meet 9/21 to review and vote on an Intarcia Therapeutics NDA for ITCA 650 (exe...
