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

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

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

The initiative, referred to as the Commissioner's National Priority Voucher program, allows drug developers to participate in ...

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

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

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

An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...

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

The FDA is launching a National Priority Voucher program to accelerate reviews of certain new drug applications. The agency will distribute a limited number of vouchers in the program’s first year to ...

The Food and Drug Administration has gone all in on AI since Martin Makary, M.D., took over the agency, most recently ...