Chester County News and Community Website
WASHINGTON, D.C. — In a landmark move to improve transparency and modernize regulatory processes, the U.S. Food and Drug Administration (FDA) has published more than 200 complete response letters (CRLs) …
FDA Publishes Over 200 Complete Response Letters to Increase Drug Approval Transparency Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) is calling on manufacturers and distributors of infant formula, baby foods, and other foods intended for children to strengthen and …
FDA Urges Stronger Recall Communications to Protect Children’s Food Safety Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently announced it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) requirements for all currently approved BCMA- and CD19-directed …
FDA Removes REMS Requirements for CAR T Cell Therapies, Boosting Patient Access Read More
PHILADELPHIA, PA — The U.S. Food and Drug Administration (FDA) this week approved GSK‘s 200 mg/mL autoinjector of Benlysta (belimumab) for use in children aged five and older who are …
FDA Approves Benlysta Autoinjector for Pediatric Lupus Nephritis Treatment Read More
WILMINGTON, DE — The U.S. Food and Drug Administration (FDA) has granted accelerated approval to DATROWAY® (datopotamab deruxtecan-dlnk) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated …
FDA Grants Accelerated Approval for DATROWAY in Advanced EGFR-Mutated Lung Cancer Read More
BALA CYNWYD, PA — Larimar Therapeutics, Inc. (Nasdaq: LRMR) has announced an updated timeline for submitting its Biologics License Application (BLA) for nomlabofusp, a potential first-in-class treatment for Friedreich’s Ataxia …
Larimar Therapeutics Aligns with FDA Guidance, Revises Nomlabofusp Submission Timeline Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has initiated an immediate review of clinical trials involving the international transfer of Americans’ living cells for genetic engineering and subsequent …
FDA Investigates Clinical Trials Sending U.S. DNA Overseas 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 Centers for Disease Control and Prevention (CDC) has issued a food safety alert following a multistate outbreak of Salmonella infections linked to pistachio cream. Four individuals in …
CDC Warns of Salmonella Outbreak Linked to Pistachio Cream Read More
WILMINGTON, DE — The U.S. Food and Drug Administration (FDA) has announced a three-month extension for its review of the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura®), submitted …
FDA Extends Review Period for Ruxolitinib Cream for Pediatric Atopic Dermatitis Read More