Begins rolling FDA NDA for QTORIN 3.9% rapamycin gel in microcystic lymphatic malformations
Completion of the NDA remains targeted for H2 2026 under FDA rolling review, supported by Breakthrough Therapy and Fast Track designations. - Preparing for potential US launch in H1 2027, pending FDA clearance.
Completion of the NDA remains targeted for H2 2026 under FDA rolling review, supported by Breakthrough Therapy and Fast Track designations. - Preparing for potential US launch in H1 2027, pending FDA clearance.