The Food and Drug Administration has accepted and granted priority review to a new drug application for sunvozertinib.
The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.
An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time ...
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
Arrowhead Pharmaceuticals said Friday that the Food and Drug Administration accepted the company's new drug application for its treatment of familial chylomicronemia syndrome, a severe and rare ...
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...
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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.
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...
The new prefilled syringe has the same composition but removes the need for reconstitution, providing a more convenient option for health care providers who administer vaccines. According to the ...
FDA denies Vanda's Tradipitant application for gastroparesis, urging new trials for efficacy and safety. Vanda disputes the ...
The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell lung cancer. The Food and Drug Administration (FDA) has accepted a new drug ...
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