US FDA approves Mirum Pharma's genetic disorder drug
The U.S. Food and Drug Administration approved Mirum Pharmaceuticals' genetic disorder drug on Friday, making it the first ...
Ozempic and Wegovy officially moved off FDA’s drug shortage list
Ozempic and Wegovy, the widely popular forms of semaglutide sold to treat diabetes and obesity, have officially been removed ...
Yearslong Shortage of Popular Weight-Loss and Diabetes Drugs Is Resolved, FDA Says
Federal regulators say shortages of Ozempic and Wegovy have been resolved, as supplies of popular diabetes and obesity ...
Generic Wegovy, Ozempic compounds may become harder to get as FDA removes drug from shortage list
Compounding pharmacies producing cheaper semaglutide products have been given notice they will soon have to stop, as the drug ...
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FDA approves first treatment for rare lipid storage disease
The FDA has approved Ctexli for the treatment of cerebrotendinous xanthomatosis (CTX), a rare lipid storage disease, in ...
US FDA approves SpringWorks' genetic disorder drug
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of noncancerous tumors on ...
FDA Approves Mirum Pharmaceuticals Treatment for Lipid-Storage Disease
The Food and Drug Administration approved Mirum Pharmaceuticals' Ctexli to treat Cerebrotendinous Xanthoma, a very rare lipid-storage disease. The approval makes Ctexli, or chenopod, the first ...
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FDA Drug Approval Decisions Expected in March 2025
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...
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FDA approves drug for neurofibromatosis
The US Food and Drug Administration has approved mirdametinib for the treatment of neurofibromatosis type 1 (NF1) in adults ...
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FDA approves first drug to aid sleep apnea; drug also results in weight loss
The FDA approved a new drug called Zepbound, which activates GLP-1 to help with obstructive sleep apnea, while also resulting ...
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FDA-approved devices used to treat cardiovascular diseases
Heart disease, also called cardiovascular disease, can have serious consequences. It's the leading cause of death for adults in the U.S. Medical devices approved by the U.S. Food and Drug ...