As one long-running feud over the controversial generic drug carveout known as “skinny” labeling comes to a close, the United States’ top lawyer is urging the Supreme Court to reverse a recent ...
The federal government re-ignited a controversial proposal to give generic drug makers the power to unilaterally update product labels to reflect new safety information, a proposal that drew criticism ...
The U.S. Court of Appeals for the Federal Circuit sided with a jury’s 2017 finding that Teva swayed doctors away from using GlaxoSmithKline’s drug Coreg (carvedilol) for a use of its drug that was ...
(Reuters) - The U.S. Food and Drug Administration on Tuesday defended its proposal to require generic drugmakers to update the prescribing information on their products if they become aware of new ...
Aydin Harston Ph.D., Anh-Thu Lam, Ph.D. On January 16, 2026, the U.S. Supreme Court agreed to hear Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., a patent dispute that could reshape the ...
Evidence suggests commercial health plans are more likely to delay specialty drug coverage decisions in response to FDA ...
The vast majority of patients who initiated imatinib therapy for gastrointestinal stromal tumors (GISTs) received a generic drug that did not have FDA approval for that indication, a large ...
After a ‘skinny label’ was used to market a generic version of a pricey brand-name medicine, more consumers gained access to the lower-cost copycat drug and saved on out-of-pockets cost, a new study ...
The program has demonstrated savings but legal challenges threaten its future. Medicare Part D saved nearly $15 billion over six years with the use of "skinny label" generics, a new report says.
Children with primary immunodeficiencies often had drug allergy labels, almost all of which were not confirmed when evaluated ...
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