Tag: FDA

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...

Future of Life Sciences Documentation: AI, Automation, and the Road to Intelligent Workflows Comprising medical equipment, biotechnology, and drugs, the life sciences sector works in...

Transformational Pharmaceutical Documentation: AI-Driven Structured Content for Compliance, Effectiveness, and Innovation Among the most under control and documentation-intensive industries worldwide is the pharmaceutical one.  From...