A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...

The FDA has granted Priority Review to nipocalimab for the treatment of antibody positive patients with generalized myasthenia gravis.

A Prescription Drug User Fee Act target date of May 27, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application ...

has accepted for priority review a supplemental new drug application (sNDA) seeking approval of WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the ...

The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...

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The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...

Starlink has the potential to offer faster speeds than Hughesnet or Viasat (not to mention other popular rural internet ...

The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025. The FDA granted priority review to a supplemental new ...

Want a cruise that's affordable, fun and sails from Florida but without all the drama of some other lines? Margaritaville at ...

The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for Welireg (belzutifan), Merck & Co’s (NYSE: MRK) oral hypoxia-inducible factor-2 ...

Florida Rep. Brian Mast schooled CBS journalist Margaret Brennan over 'woke' spending in the U.S. Agency for International ...