By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...
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.
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 ...
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 ...
The CMS created ACCESS to address barriers to care stemming from Medicare’s fee-for-service payment model. Rather than pay for specific services, Medicare will make recurring payments to healthcare ...
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 — ...