FDA Accepts TransCon® CNP NDA for Priority Review

FDA Accepts TransCon® CNP NDA for Priority Review

– Once-weekly TransCon CNP demonstrated significantly higher annualized growth velocity, the primary endpoint, compared to placebo

FDA accepts navepegritide application to treat children with achondroplasia

With the new drug application accepted with priority review, the FDA has assigned a date of November 20, 2025, to complete its review for potential approval.

FDA Requests Additional Data for Savara's MOLBREEVI Application

LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has announced receiving a Refuse-to-File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) of MOLBREEVI, a potential treatment for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The letter, issued after a preliminary review, noted that the BLA submitted in March 2025 was incomplete, requiring additional Chemistry, Manufacturing, and Co…