Palvella announces FDA acceptance and priority review of Qtorin rapamycin NDA; February 28, 2027 PDUFA target date set
PVLA•Palvella Therapeutics said the FDA accepted and granted priority review to its Qtorin rapamycin NDA, setting a February 28, 2027 PDUFA target action date. The company is preparing for a potential U.S. commercial launch in the first half of 2027.
1. FDA review
Palvella Therapeutics said the FDA accepted its Qtorin rapamycin NDA for priority review and set a February 28, 2027 PDUFA target action date. The company said it is preparing for a potential U.S. commercial launch in the first half of 2027.
