On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic ...

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...

By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...

On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to ...

SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company’s novel ...

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly//File Photo Dec 9 (Reuters) - The U.S.

FDA commissioner Dr. Marty Makary is beginning to make moves toward his promise of speeding up drug approval pathways at the agency. But he’s aiming to do things a bit differently than in the past — ...