FDA Grants Breakthrough Therapy and Fast Track Designations to Protara Therapeutics for TARA-002

Reuters
Jan 05
FDA Grants Breakthrough Therapy and <a href="https://laohu8.com/S/FTRK">Fast Track</a> Designations to Protara <a href="https://laohu8.com/S/LENZ">Therapeutics</a> for TARA-002

Protara Therapeutics Inc. has received both Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration (FDA) for its investigational therapy TARA-002, aimed at treating pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs). Additionally, TARA-002 was selected to participate in the FDA's Chemistry, Manufacturing, and Controls $(CMC)$ Development and Readiness Pilot (CDRP) Program, which supports the development of therapies with expedited clinical timelines. The therapy had previously been granted Rare Pediatric Disease designation for the treatment of LMs. No other beneficiary organizations were mentioned.

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