A former critic of FDA and Pharma will now oversee the regulation of costly and complicated biologics like vaccines, gene therapies, and blood supply.

The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of ...

Q1 2025 Earnings Call Transcript May 8, 2025 Crinetics Pharmaceuticals, Inc. misses on earnings expectations. Reported EPS is ...

Q1 2025 Earnings Call Transcript May 8, 2025 Iovance Biotherapeutics, Inc. misses on earnings expectations. Reported EPS is $ ...

The expansion builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program ...

General and Administrative (G&A) Expenses. G&A expenses for the three months ended March 31, 2025 were $6.9 million compared to $5.1 million for the same period in 2024. The increase was primarily ...

FDA will implement a secure generative AI system across all centers by June 30, aiming to streamline internal reviews and ...

This week, underscoring a commitment to national security, the White House and the Food and Drug Administration (FDA) issued ...

FDA's plan to deploy an AI tool to assist with scientific review process raises questions about transparency and risks.

Commissioner Martin Makary also said the agency would roll out a generative AI system across its centers that will help FDA ...