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WILMINGTON, DE — AstraZeneca and Daiichi Sankyo announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to their supplemental Biologics License Application (sBLA) for …
FDA Grants Priority Review for ENHERTU Combo in Advanced Breast Cancer Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has granted accelerated approval to Forzinity (elamipretide) injection, the first treatment for Barth syndrome, a rare and life-threatening mitochondrial disease that …
FDA Approves First Drug for Rare, Fatal Barth Syndrome Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) announced a series of actions last week aimed at strengthening consumer protections, advancing rare disease treatment development, and improving drug …
FDA Issues Series of Regulatory Actions Targeting Public Health, Transparency, and Drug Safety Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has unveiled the Commissioner’s National Priority Voucher (CNPV) program, aiming to streamline the drug approval process and address critical health …
FDA Introduces Priority Voucher Program to Accelerate Drug Approvals Read More
WASHINGTON, D.C. — The Food and Drug Administration announced plans to create a Rare Disease Innovation Hub to accelerate the development of treatments for rare diseases. This initiative, detailed in …
FDA Launches Rare Disease Innovation Hub to Boost Treatment Development Read More
WASHINGTON, D.C. — On Thursday, U.S. Senators Bob Casey (D-PA) and Markwayne Mullin (R-OK) introduced the Creating Hope Reauthorization Act, a bipartisan effort aimed at encouraging pharmaceutical companies to develop …
Senate Leaders Push for Reauthorization of Program to Combat Rare Pediatric Diseases Read More