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WASHINGTON, D.C. — Federal regulators are advancing new safety standards for gene-editing therapies, aiming to speed development of treatments for rare and previously incurable diseases while tightening oversight of potential …
FDA Moves to Fast-Track Gene Editing Safety Standards Read More
WASHINGTON, D.C. — Federal regulators are pushing thousands of companies and researchers to disclose missing clinical trial results, warning that gaps in reporting may distort how drugs and medical products …
FDA Presses Firms to Report Missing Clinical Trial Results Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) recently submitted an updated Phase 2 clinical study design to the U.S. Food and Drug Administration for Teverelix, an investigational treatment aimed …
Medicus Submits Phase 2 Study Design for Teverelix to FDA Read More
WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) recently received preliminary feedback from the U.S. Food and Drug Administration on labeling for its preservative-free ketamine product, as the company continues …
NRx Receives FDA Feedback on Ketamine Drug Labeling Read More
PHILADELPHIA, PA — The U.S. Food and Drug Administration recently granted Breakthrough Therapy Designation to plixorafenib, an investigational drug from FORE Biotherapeutics, for the treatment of adults with BRAF V600E-mutated …
FDA Grants Breakthrough Status to Fore Bio Brain Cancer Drug Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) said it has submitted an optimized Phase 2 clinical trial protocol to the U.S. Food and Drug Administration for teverelix, an investigational …
Medicus Pharma Submits Phase 2 Protocol for Teverelix to FDA Read More
WASHINGTON, D.C. — A new weight-loss drug is now available months ahead of schedule after the U.S. Food and Drug Administration approved Foundayo (orforglipron) in just 50 days, marking one …
FDA Fast-Tracks New Weight-Loss Drug in Record Time Read More
PHILADELPHIA, PA — iECURE said the U.S. Food and Drug Administration has selected ECUR-506, the company’s investigational gene insertion therapy for neonatal-onset ornithine transcarbamylase deficiency, for the agency’s Chemistry, Manufacturing, …
FDA Selects iECURE Therapy for Manufacturing Readiness Pilot Program Read More
WASHINGTON, D.C. — Consumers will see clearer labeling on meat, poultry, and egg products under a new federal standard designed to ensure items labeled “Product of USA” are entirely sourced …
New ‘Product of USA’ Label Targets Consumer Confusion Read More
WASHINGTON, D.C. — Children with a life-threatening immune disorder now have a new treatment option following federal approval of the first gene therapy designed to correct the underlying cause of …
FDA Approves First Gene Therapy for Rare Childhood Immune Disorder Read More