Gedatolisib's NDA for advanced breast cancer treatment has been accepted by the FDA, with a priority review and a PDUFA date set for July 17, 2026. The drug is intended for HR+/HER2–, PIK3CA wild-type ...
FDA grants Breakthrough Therapy designation to ianalumab for Sjögren disease after the monoclonal antibody showed significant disease improvement.
In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market ...
New sublingual delivery system designed to enhance bioavailability and speed of onset for major depressive and ...
The healthcare giant just took a major step that could reshape its MedTech business and boost its dividend track record.
Malaria remains a major global public health challenge, with millions of cases reported annually despite sustained control ...
PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus ...
FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026MINNEAPOLIS, (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: ...
Cresco Spine announced that the U.S. FDA has granted 510(k) clearance for the Spring Distraction System (SDSTM), for the ...
The U.S. Food and Drug Administration signaled a sweeping shift in how cutting-edge therapies reach patients this month, ...
The FDA commissioner's effort to shorten the review of drugs favored by the Trump administration is causing alarm across the ...
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