The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.
The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.
The FDA has accepted Merck's (MRK) supplemental NDA with priority review for its drug Welireg for the treatment of a rare ...
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date ...
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 ...
A D.C. drugmaker is fighting the FDA on multiple fronts, from trying protect its intellectual property from generic ...
The FDA will review a new prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted).
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...
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