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Received FDA Complete Response Letter; resubmitting NDA in Q3 2026 after human factors and PK studies
For nearly four decades, Americans facing life-threatening allergic reactions had exactly one option: stab themselves with a needle. The EpiPen and its competitors delivered epinephrine effectively, but needle phobia kept roughly 30% of patients from using their prescribed devices during emergencies—contributing to preventable deaths. Now the needle era is ending.
Updated May 23
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