Tag: FDA

The U.S. Food and Drug Administration has initiated a new phase of stakeholder engagement for its national priority voucher pilot program, announcing a public...

Novartis has received approval from the US Food and Drug Administration (FDA) for Cosentyx (secukinumab) for the treatment of paediatric patients aged 12 years...

The U.S. Food and Drug Administration on Tuesday authorized the use of leucovorin, a long-established generic medicine, for the treatment of a rare genetic...

The supplemental Biologics License Application - sBLA for Enhertu - trastuzumab deruxtecan by AstraZeneca and Daiichi Sankyo has been accepted as well as granted...

Johnson & Johnson (J&J) has obtained approval from the US Food and Drug Administration (FDA) for a revised dosing schedule of Rybrevant Faspro (amivantamab...

The U.S. Food and Drug Administration – FDA on December 22, 2025, gave an approval to the first GLP-1 pill for obesity from Novo Nordisk,...

Risk management in pharma is often treated as a reactive compliance box-ticking exercise. This article argues for reframing risk as a strategic competitive advantage. It details proactive frameworks like the "Excipient Exclusion Filter," Decision Quality (DQ) matrices, and "pre-mortem" analyses that allow development teams to anticipate failure modes and engineer them out of the pipeline before they occur.