Enhertu plus Perjeta received FDA priority review for first-line treatment of HER2-positive metastatic breast cancer, showing significant improvements in progression-free survival and response rates.
The FDA awarded two national priority review vouchers through its Commissioner’s National Priority Voucher pilot program on Dec. 19, bringing the total granted to 18. The latest vouchers were issued ...
Priority Review granted for CUTX-101 could expedite its path to market, potentially becoming the first FDA-approved treatment for Menkes disease. Cyprium is eligible to receive up to $129 million in ...
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FDA layoffs and priority review voucher programme’s lapse disrupt rare disease pipeline
Against the stark backdrop of the FDA job cuts, stakeholders in the rare disease space find themselves facing heightened uncertainty. In late March 2025, the Trump administration moved forward with ...
CEO Linda Marban highlighted the acceptance by the FDA of Capricor's Biologics License Application (BLA) for deramiocel, targeting treatment of Duchenne muscular dystrophy (DMD) cardiomyopathy. The ...
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