While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...

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 ...

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 ...

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

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

Mumbai: Global pharma major Lupin Limited has launched Prucalopride Tablets, 1 mg, and 2 mg, in the United States, following ...

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

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

NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with ...

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