The New Drug Application (NDA) for sepiapterin is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of July 29 ...

These data provide further evidence of the potential meaningful benefits of sepiapterin treatment for the full spectrum of phenylketonuria (PKU) patients, including significant diet liberalization.

The New Drug Application for sepiapterin is under review by the FDA with a Prescription Drug User Fee Act target action date of July 29. Discover outperforming stocks and invest smarter with Top ...

Meanwhile, the U.S. Food and Drug Administration (FDA) is reviewing the New Drug Application (NDA) for sepiapterin, with a decision expected by July 29, 2025. Globally, an estimated 58,000 people ...

PTC submitted four FDA applications, all under review. Vandana Singh PTC Therapeutics Reveals New Sepiapterin Data From Phase 3 Study In Patients With Inherited Disorder, FDA Decision Expected In ...

— Results show 97% of phenylalanine (Phe) tolerance study participants were able to increase ...

Meanwhile, the U.S. Food and Drug Administration (FDA) is reviewing the New Drug Application (NDA) for sepiapterin, with a decision expected by July 29, 2025. Globally, an estimated 58,000 people live ...