Chester County News and Community Website
PHILADELPHIA, PA & LONDON — Ori Biotech announced that its IRO® platform has received Advanced Manufacturing Technology (AMT) designation from the U.S. Food and Drug Administration, marking it as one …
Ori Biotech’s IRO Platform Earns FDA Advanced Manufacturing Technology Designation 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. Department of Agriculture (USDA) released a series of updates last week addressing public health, environmental policy, and food supply security. The announcements included confirmation of a …
USDA Announces New Health, Land, and Veterinary Initiatives Amid Traveler-Linked New World Screwworm Case Read More
Since the launch of the second Trump Administration, I’ve noticed a growing number of complaints about our coverage of federal agencies and government departments. Some readers seem convinced that reporting …
Reporting Government Actions Isn’t Propaganda — It’s Journalism Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved Papzimeos (zopapogene imadenovec-drba), marking the first approved medical therapy for adults with recurrent respiratory papillomatosis (RRP), a rare …
FDA Approves First Immunotherapy for Rare Respiratory Papillomatosis Read More
WASHINGTON, D.C. — Federal regulators are moving to ease diesel exhaust fluid (DEF) rules that have triggered sudden speed and power losses in trucks and equipment, unveiling guidance that urges …
EPA, SBA Move to Curb DEF-Related Shutdowns, Projecting Major Savings for Family Farms Read More
EXTON, PA — Lungpacer Medical Inc. has secured a significant reimbursement boost for its AeroPace® System, with the Centers for Medicare & Medicaid Services (CMS) granting New Technology Add-on Payment …
CMS Grants NTAP Status to Lungpacer’s AeroPace System, Boosting Hospital Reimbursement Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration has unveiled FDA PreCheck, a new initiative designed to strengthen the domestic pharmaceutical supply chain by making the process of building …
FDA Launches PreCheck Program to Boost Domestic Drug Manufacturing Read More
NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) announced a major expansion to the patient eligibility criteria for its ongoing BACKBEAT study, aimed at evaluating the effectiveness of its …
FDA Greenlights Broader Patient Access for AVIM Therapy Trial in Pacemaker Patients Read More
WILMINGTON, DE — The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) in the treatment of …
AstraZeneca’s IMFINZI® Granted Priority Review for Early-Stage Gastric Cancer Treatment Read More