Tag: FDA

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.

The "Valley of Death" in pharma is no longer just about scientific failure; it is about commercial irrelevance. This article examines the critical need to align R&D ambition with market reality early in development. It explores the evolution of the Target Product Profile (TPP) into the Target Value Profile (TVP), the role of the "commercial scientist," and strategies for integrated evidence generation that satisfy both regulators and payers.

On December 12, 2025, the U.S. health regulator went ahead and approved the oral antibiotic by Innoviva for treatment of gonorrhea, which is a...