Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense Trial will enroll ...

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

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

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

Novo Nordisk said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense race to get an oral weight-loss medication on ...

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 ...

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