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The approval makes Wegovy the only GLP-1 therapy cleared to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. About 14.9 million U.S. adults — or roughly 6% of the population — have the condition, according to the FDA.
The Food and Drug Administration has authorized emergency use of animal drugs to treat and prevent infestations of the New World Screwworm, which poses an emerging threat to U.S. livestock and food security.
The test is the only FDA-approved companion diagnostic panel for identifying colorectal cancer patients for specific immunotherapy treatments. Mismatch repair deficiency or microsatellite instability-high status is present in 5% to 15% of colorectal ...
(Reuters) -The U.S. health regulator has allowed a study of Rocket Pharmaceuticals' gene therapy to resume, less than three months after halting it following a patient's death. The drugmaker's shares soared over 30% in morning trading on Wednesday.
PTC Therapeutics has not provided substantial evidence that vatiquinone is effective in treating children and adults with Friedreich’s ataxia, the FDA told the company in a complete response letter, according to a press release.
A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules and promoting fringe views about antidepressants and other products.
With the landmark FDA approval of Papzimeos and broad label, all adult RRP patients are now eligible for access to the first and only approved therapy that targets the root cause of the disease." Approval of Papzimeos was granted to Precigen.
The FDA has accepted Stealth BioTherapeutics’ third new drug application for its ultra rare disease candidate, providing a
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