Company expects up to six-month review period per FDA guidelines New longer-term clinical data demonstrating durable positive brain biochemical and clinical effect for as long as 8.5 years to be ...

Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that the U.S. Food & Drug ...

ALACHUA, Fla. and TAMPA, Fla., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (AXGN), a global leader in developing and marketing innovative surgical technologies for the restoration of peripheral ...

D-VRd is the only quadruplet regimen approved for patients with newly diagnosed multiple myeloma, irrespective of transplant ...

Summit Therapeutics SMMT announced that the FDA has accepted its biologics license application (BLA) seeking approval for ...

The FDA accepted an application for ivonescimab with chemotherapy for patients with lung cancer driven by EGFR changes after ...

Please provide your email address to receive an email when new articles are posted on . Leqembi Iqlik is the first approved in-home anti-amyloid injectable for early Alzheimer’s disease. Patients ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

Mesoblast reports early real-world data showing 84% survival in children treated with FDA-approved Ryoncil, as the company expands hospital access and prepares an adult trial.

The U.S. Food and Drug Administration (FDA) has granted full approval of Laverdia, a drug to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system.

The new generic drug has been approved for treatment of bovine respiratory disease and associated pyrexia in beef and ...