Revuforj is designed to treat patients with relapsed or refractory mutant NPM1 acute myeloid leukemia. The application has been assigned a real-time oncology review, which allows for a more efficient ...

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

In a Phase I/II clinical trial, TKI-pretreated NSCLC patients given zidesamtinib had an overall response rate of 44 percent.

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 ...

Doctors say there have been a number of developments with new weight loss drugs, which could make them easier for patients to ...

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

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 ...

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

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 ...