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The Food and Drug Administration has finalized its decision to call an end to the drug shortage of Eli Lilly's blockbuster GLP-1 products, often referred to by their formula name, tirzepatide.Eli ...
The FDA's decision is a win for Lilly, the drug's manufacturer, according to the Associated Press, prices and ways to access drugs like Zepbound and Mounjaro could be affected as a result of the move.
The FDA's decision came as a surprise to company officials and many Alzheimer's experts, who had expected a full approval for Lilly's drug donanemab this month based on clinical trial data last ...
The court in December took up the Biden administration's appeal in defense of the later FDA decisions, but it opted against hearing the challenge to the original approval of mifepristone in 2000.
FDA v. Wages and White Lion Investments, L.L.C. 23-1038: Whether the U.S. Court of Appeals for the 5th Circuit erred in setting aside FDA’s denial orders of respondents' applications for authorization to market new e-cigarette products as arbitrary and capricious. July 2, 2024: December 2, 2024 Feliciano v. Department of Transportation: 23-861
The court in December took up the Biden administration’s appeal in defense of the later FDA decisions, but it opted against hearing the challenge to the original approval of mifepristone in 2000.
Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367 (2024), was a United States Supreme Court case to challenge the U.S. Food and Drug Administration (FDA)'s approval of mifepristone, a drug frequently used in medical abortion procedures.
The decision was announced after the company agreed to pay $36.9 million to resolve criminal charges and civil liability in connection with InterMune's off-label promotion of the drug, which had only been approved by the FDA to treat chronic granulomatous disease and severe malignant osteopetrosis, both extremely rare illnesses which would have ...