The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and ...
The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC) and prescription drugs. One of the ...
FDA’s final SIUU guidance loosens some off-label communication rules, but drugmakers still face strict compliance demands to stay within the safe harbor.
The U.S. Food and Drug Administration has approved a label expansion for Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo ...
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 ...
The FDA has added new warnings to GLP-1 medications such as Ozempic, Wegovy, and Mounjaro about pulmonary aspiration risk ...
A common drug combo for Parkinson’s disease will require a new FDA warning after the agency flagged 14 cases of seizures in patients using the medications. The agency is mandating (PDF) that ...
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