Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved the use of gardenia (genipin) blue as a color additive in a range of food products, marking the fourth …
FDA Approves Gardenia Blue as Natural Dye in Major Move to Eliminate Synthetic Food Colors Read More
WASHINGTON, D.C. — Federal health authorities are investigating a multistate Salmonella outbreak linked to frozen sprouted beans sold under the Deep brand, prompting an urgent recall and public health warning. As …
Frozen Sprouted Beans Recalled Nationwide After Salmonella Outbreak Hospitalizes Four Read More
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