The Research to Accelerate Cures and Equity for Children Act(RACE)-goes into effect August 18th. The RACE Act amends the existing PREA-Pediatric Research Equity Act-and eliminates the exemption from PREA requirements for cancer drugs that have orphan status. The new law requires pediatric evaluation of new drugs intended for the treatment of adult cancers and directed at a molecular target substantially relevant to the growth or progression of pediatric cancer. A designated PRA team is ready to utilize their collective experience in pediatric clinical development to support RACE Act-focused initiatives.
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FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
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June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
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