FDA grants rolling review for Palvella's rapamycin NDA for rare condition
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FDA Grants Rolling Review of Palvella’s QTORIN™ Rapamycin NDA for Microcystic Lymphatic Malformations
June 22, 2026 7:30 AM EDTFDAs rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed sections of the NDA before the full application is submitted
Palvella remains on track to complete the NDA submission in the second half of 2026
QTORIN rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 30,000 individuals with microcystic lymphatic malformations in the U.S.
WAYNE, Pa., June 22, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the Company) (Nasdaq:... More
