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Agios announces the submission of its sNDA to the FDA for the U.S. accelerated approval of mitapivat in sickle cell disease

White Oak, Md., May 11, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced it is soliciting input on efforts with respect to drug repurposing to help address unmet...

MoonLake conducted a positive final pre-BLA (Biologics License Application) meeting with the U.S. Food and Drug Administration (FDA), where MoonLake and the FDA aligned on submission plans and the...

White Oak, Md., May 08, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive...

White Oak, Md., May 08, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today issued a final guidance for industry, Postapproval Pregnancy Safety Studies, with recommendations on...

Austin, TX, USA, May 08, 2026 (GLOBE NEWSWIRE) -- Custom Market Insights has published a new research report titled “Surgical Case Carts Market Size, Trends and Insights By Type (Open Case Cart,...

White Oak, Md., May 06, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a...

White Oak, Md., May 06, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make...

Diathrive Health and AliveCor announced partnership to deliver a more comprehensive approach to cardiometabolic care for employers

White Oak, Md., May 05, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the...