Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.
News|Articles|March 26, 2025
Q2 2025: 10 FDA Decisions to Watch
Author(s)HCPLive Editorial Staff
Fact checked by: Patrick Campbell
A Q2 2025 preview spotlighting 10 FDA decisions to watch, including upcoming PDUFAs for dupilumab, pz-cel, ketamine, clesrovimab, and more!
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The first quarter of 2025 set a high bar for drug approvals, with the US Food and Drug Administration (FDA) greenlighting several groundbreaking therapies. Suzetrigine (Journavx), a nonopioid pain reliever, broke a decades-long drought in FDA approvals for this critical area of unmet need. Meanwhile, semaglutide (Ozempic) expanded its reach, earning an indication for chronic kidney disease in type 2 diabetes, and esketamine (Spravato) made history as the first monotherapy for treatment-resistant depression.
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Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.
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