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- FDA grants accelerated approval for Etcamah combo therapy for advanced HR-positive, HER2-negative breast cancerThe U.S. Food and Drug Administration announced accelerated approval of Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone-receptor-positive, HER2-negativ…
- FDA releases draft guidance on evaluating drug behavior in patients with liver impairmentThe FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…