BioPharma Dive

5 FDA decisions to watch in the first quarter of 2026

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

FDA-Authorized Expanded Access Programs Utilizing Jaguar Health’s Novel Crofelemer Powder for Oral Solution to Treat Two Pediatric Intestinal Failure Patients with ...

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 ...
Yahoo

US FDA approves first drug under new fast-track review program

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.
MM&M

FDA’s new national priority voucher program wants to speed up drug approvals while lowering drug costs

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 — ...
MD&M East

FDA Expands Medical Device Recall Alert Program

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...
Becker's Hospital Review

Lawmakers raise concerns over FDA drug voucher program

Lawmakers are pressing the FDA for answers about its Commissioner’s National Priority Voucher program, voicing concerns over potential corruption, safety risks and transparency issues. In a Nov. 20 ...