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

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

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 ...

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

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 ...

Novo Nordisk NOVO.B0.48%increase; green up pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense ...

of its investigational new drug application (IND) for AVZO-1418/DB-1418, a potential best-in-class, novel EGFR/HER3 bispecific antibody-drug conjugate (ADC). On January 7th, 2025, DualityBio and ...

Aldeyra plans to resubmit the new drug application with new trial data later this year. Perspective from Darrell E. White, MD The FDA issued a complete response letter for the resubmission of the ...