On January 16, 2026, the U.S. Supreme Court announced its intent to hear the case of Hikma v. Amarin. This case follows the landmark GSK v. Teva ...
A US Supreme Court fight over how branded drugs’ makers must plead induced infringement in “skinny-label” patent suits could ...
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) ...
The Supreme Court agreed to review a controversy over so-called skinny labels for medicines, a decision that will be closely ...
Project Renewal updates older oncology drug labels to ensure clinical relevance and scientific accuracy, involving external experts and early-career scientists. Fludarabine phosphate's updated label ...
Current Federal Drug Administration regulations require a generic drug’s labeling to be the same as its brand-name counterpart. Brand-name drug manufacturers are able to update product labels with new ...
Please provide your email address to receive an email when new articles are posted on . Mebeverine was not superior to placebo, with similar treatment success and symptom relief reported between ...
Developing standards for the conversion of paper labeling to an electronic format is a high priority for FDA. The content and format revisions to the prescribing ...
Physicians are increasingly prescribing medications off-label to children, with one-fifth of all pediatric physician visits resulting in off-label prescriptions, according to a study published in ...
The Food and Drug Administration approved on Friday a label change for Pfizer's birth control shot Depo-Provera that warns patients of the risk of meningioma, a tumor in the lining of the brain.
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