AdvaMedDx calls for two substantive changes to an FDA draft guidance on the enforcement policy for certain in vitro diagnostic devices for immediate p...
FDA grants PharmasstX an orphan drug designation for epigallocatechin gallate, a green tea extract for treating inflammatory bowel disease pouchitis.
FDA researchers stress the need for more payer involvement in evidence generation to support clinical practice following drug approvals.
FDA approves an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) cream, 0.15%, for treating mild to moderate atopic dermatitis.
FDA grants Longeveron a Regenerative Medicine Advanced Therapy designation for Lomecel-B and its use for treating mild Alzheimers Disease.
FDA posts 30 signals of serious risks/new safety information identified by the FAERS in the first quarter of 2024 and is evaluating the need for regul...
FDA approves a Cordis PMA for its Mynx Control Venous Vascular Closure Device for use in certain cardiac ablation procedures.
FDA cautions healthcare providers and facilities to heed a Medtronic urgent recall of all models and lots of its NIM EMG Contact and Standard endotrac...
