The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
A provision about insulin in the Inflation Reduction Act is conflated with a 2022 executive order by former President Joe ...
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.
"We are pleased the FDA has accepted our NDA for Bumetanide Nasal Spray," said Benjamin Esque, CEO of Corstasis Therapeutics ...
Milestone Pharmaceuticals (MIST) provided a corporate update and outlined its strategic priorities for 2025. CARDAMYST for Paroxysmal ...
The FDA has accepted for review the New Drug Application for plozasiran for the treatment for familial chylomicronemia syndrome.
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
GlobalData on MSN5d
Stealth faces another hurdle as FDA delays decision on Barth syndrome drugThe FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department ...
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...
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