6 FDA Decisions To Watch in Q2 2026

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The second quarter of 2026 is anticipated to be a busy one for the FDA, with several significant decisions on new therapies, including a closely watched obesity drug from Eli Lilly. Other key decisions involve Biogen’s high-dose Spinraza for SMA, Replimune’s RP1 for advanced melanoma, Axsome Therapeutics’ AXS-05 for Alzheimer’s agitation, Biogen and Eisai’s subcutaneous Leqembi, and AstraZeneca’s baxdrostat for hypertension. These regulatory verdicts could significantly impact treatment landscapes in various disease areas and intensify market competition.

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