With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is ...

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

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

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 ...

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

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 ...

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

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 ...

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

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

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