News

The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...
Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense Trial will enroll ...
Aldeyra had received 2 complete response letters (CRL) from the FDA in April 2025 and November 2023 for past submissions.
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 ...
While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...
The investigational MRI contrast agent, gadoquatrane, is designed to deliver effective imaging at a significantly reduced ...
The FDA plans to approve selected high-priority drug application submissions in 1 to 2 months rather than 10 to 12.
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 U.S. FDA is launching a program under which its commissioner can issue vouchers to companies he finds are aligned with national priorities to shorten their review time for a drug application to ...
The program will bring together experts from across the FDA for a team-based review, rather than having an application move ...