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Live News REGULATION FLASH L impact

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.

This is a real-time flash headline. A verified provider body is not available, so SquawkNews does not present it as a full article.