The U.S. FDA is launching a program under which its commissioner can issue vouchers to companies he finds are aligned with ...

The US Food and Drug Administration announced a new national priority voucher plan that aims to cut drug review times to one ...

Aldeyra had received 2 complete response letters (CRL) from the FDA in April 2025 and November 2023 for past submissions.

Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) ...

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for ...

The investigational MRI contrast agent, gadoquatrane, is designed to deliver effective imaging at a significantly reduced ...

The program will bring together experts from across the FDA for a team-based review, rather than having an application move ...

The initiative, referred to as the Commissioner’s National Priority Voucher program, allows drug developers to participate in a novel FDA priority program. The program significantly shortens the FDA ...

FDA Commissioner Martin Makary, MD, shared his vision for a “New FDA” with biopharma leaders attending BIO in Boston.

FDA assigns PDUFA target action date of January 31, 2026 WARREN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical ...

“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the ...

The FDA announced a new national priority voucher plan that aims to cut drug review times, while Headspace launches direct-to-consumer offering.