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...
The Council for Federal Cannabis Regulation says FDA should use its enforcement discretion to regulate cannabis products now while working with Congre...
FDA issues a warning against using Dr. Bernes MSM Drops 5% Solution and LightEyez MSM Eye Drops Eye Repair due to bacterial or fungal contamination....
