FDA releases the form FDA-483 with three observations issued following an inspection at the Hikma outsourcing facility in Cherry Hill, NJ.
The Duke-Margolis Institute for Health Policy issues a summary with five broad themes from a meeting co-sponsored with FDA on increasing clinical tria...
Pfizer selects its preferred once-daily modified-release formulation for danuglipron, an oral glucagon-like peptide-1 receptor agonist it is developin...
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.
