FDA issues Novo Nordisk a complete response letter on its BLA for once-weekly basal insulin icodec, indicated for treating diabetes mellitus.
The Senate Appropriations Committee marks up and approves FDAs fiscal year (FY) 2025 budget, providing a $170 million (2.5%) boost over the FY 2024 sp...
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 publishes a guidance recommending principles for use in pivotal clinical studies to demonstrate the safety and effectiveness of medical devices tr...
Kazia Therapeutics says it will meet with FDA about a potential accelerated approval pathway for its glioblastoma drug paxalisib following positive ov...
Federal Register notice: FDA announces an 8/6 public workshop entitled Artificial Intelligence (AI) in Drug & Biological Product Development.
