Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
Rahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA ...
2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of ...
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date ...
Exelixis, Inc. (Nasdaq: EXEL) today announced results from a subgroup analysis of the phase 3 CABINET pivotal study of ...
The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.
The US Food and Drug Administration (FDA) has approved Eisai and Biogen’s Supplemental Biologics License Application for once ...
Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.
Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment TOKYO and CAMBRIDGE, Mass., Jan. 26, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: ...
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FDA Expands Label of AZN's Enhertu for New Breast Cancer IndicationAstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...
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