Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato (esketamine), as the first ...
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
The U.S. Food and Drug Administration has approved Journavx (suzetrigine) 50 milligram oral tablets, marking the introduction ...
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in patients with advanced, unresectable, or metastatic pheochromocytoma and ...
The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review ... In August 2021, the drug was first approved by the FDA for the treatment of a rare ...
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