Tag: FDA

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...

The FDA has gone on to propose certain new policies in order to accelerate biosimilar drug development and at the same time also lower...

Aptar Digital Health, a global leader in digital health solutions enhancing the patient experience, today announced that the U.S. Food and Drug Administration (FDA)...

Drug developers are raising the adoption of AI technologies when it comes to discovery and safety testing in order to get rapid as well...