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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 ... "FDA’s decision today, reiterating that the ...
The FDA made it clear in its announcement that a “compounded drug may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on FDA’s drug shortage list.”
The nation’s highest court will weigh in on a challenge to the FDA’s approval of the drug Mifepristone ruling – live: Supreme Court to issue decision today in abortion pill case Skip to main ...
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 ...
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 Food and Drug Administration (FDA) said it will reconsider its decision to remove Eli Lilly’s blockbuster weight loss and diabetes drug from its official shortage list and allow compounding ...
United States of America v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014), [1] was a decision in the United States Court of Appeals for the District of Columbia Circuit filed on February 4, 2014 concerning more than minimally manipulated cell therapies and whether they are considered part of medical practice or a drug, the latter subjecting it to regulation under the Food and Drug ...
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 ...