Subcutaneous nivolumab and hyaluronidase-nvhy is FDA-approved for adult solid tumors, offering a new administration route for PD-1 inhibitors. The phase 3 CheckMate-67T trial confirmed ...

Tirzepatide is the active ingredient in Zepbound, the FDA approved prescription medicine for Obstructive Sleep Apnea. Research shows that it considerably improves the level of AHI in patients with ...

Hikma said on Monday it was “pleased to have FDA approval to launch this important medicine and to provide broader access and greater affordability for the patients who rely on it”.

Dec. 23, 2024 -- The FDA has approved the first prescription drug, Zepbound, for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity. Studies have shown that when ...

FDA approved Unloxcyt (cosibelimab-ipdl) for advanced or metastatic cSCC ahead of its PDUFA date of Dec. 28. Unloxcyt is the first PD-L1 blocking antibody approved for cSCC, with a recommended ...

This marks the first mesenchymal stromal cell therapy approved by the FDA for children with acute graft versus host disease. The Food and Drug Administration (FDA) approved Ryoncil (remestemcel-L-rknd ...

On Friday, the FDA approved Checkpoint Therapeutics, Inc.’s (NASDAQ:CKPT) Unloxcyt (cosibelimab-ipdl) for metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not ...

WALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug ...

Dec. 17, 2024 -- The FDA last week approved Nemluvio for treating moderate to severe atopic dermatitis, a type of eczema, in people aged 12 or older. Nemluvio is to be used with topical ...

However, the FDA noted in its approval announcement that there was no statistically significant difference regarding overall survival. The most common side effects experienced by at least 20% of ...

The US Food and Drug Administration (FDA) has approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for the treatment of adults with ALK-positive locally advanced or metastatic non-small cell ...

Accelerated approval was based on promising results from the ongoing Phase III BREAKWATER trial. The FDA has granted accelerated approval to Pfizer’s Braftovi (encorafenib) in combination with ...