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

Submission Seeks Approval of GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Comprehensive Data Package Includes Positive Results from Phase 3 STRIVE-ON Safety ...

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.

Centessa Pharmaceuticals (NASDAQ:CNTA) is one of the best biotech stocks to invest in now. On June 16, Centessa Pharmaceuticals announced that the US FDA cleared its Investigational New Drug/IND ...

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 ...

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 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 ...