Approval spans early and levodopa-treated disease; a 6-week titration and CYP3A interactions put pharmacists at the center of starting therapy.
News|Articles|August 21, 2026
8 PDUFA Dates to Watch in Fall and Winter 2026
Author(s)Luke Halpern, Associate Editor
Fact checked by: Ron Panarotti
Cardiomyopathy, hepatitis B, breast cancer, hypertension, and myeloma decisions land in the FDA's final-quarter queue.
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The FDA's calendar through the close of 2026 carries decisions that pharmacists across oncology, cardiology, nephrology, immunology, and infectious disease will want to track. Dozens of Prescription Drug User Fee Act (PDUFA) target action dates fall between September and December, several of them tied to potential first-in-class approvals or first pediatric indications. Here are 8 key pending dates and why each matters at the point of care.
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