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 FDA announced a new initiative to offer expedited reviews for new medicines that administration officials determine promote "the health interests of Americans." ...

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

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 ...

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

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

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 ...

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

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