Chester County News and Community Website
WASHINGTON, D.C. — U.S. regulators authorized Abbott Diabetes Care’s Libre Duo 10 Day for people with diabetes aged 2 and older, introducing the first U.S. wearable capable of continuously monitoring …
FDA Clears Abbott Device to Continuously Track Ketones, Glucose Read More
WASHINGTON, D.C. — The Food and Drug Administration last week granted accelerated approval to Ultragenyx Pharmaceutical Inc.’s Genglycos, the first treatment for glycogen storage disease type Ia, after a clinical …
FDA Clears First Gene Therapy for Rare Glycogen Disorder Read More
WASHINGTON, D.C. — The Food and Drug Administration last week authorized the first standalone robotic device capable of drawing blood without hands-on operator intervention, allowing a single trained phlebotomist to …
FDA Clears Robotic Blood Draws to Ease Staffing Shortages Read More
WASHINGTON, D.C. — A Cyclospora outbreak linked to recalled iceberg lettuce from central Mexico has sickened 10,930 people across 17 states, including Pennsylvania, leaving 454 hospitalized and two dead, federal …
Lettuce Outbreak Reaches 10,930 Cases Across 17 States Read More
WASHINGTON, D.C. — The Food and Drug Administration last week proposed a potential regulatory framework for medical devices powered by generative artificial intelligence, opening scrutiny of how manufacturers assess safety, …
FDA Weighs New Safety Rules for Generative AI Medical Devices Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration proposed requiring food manufacturers to disclose when they determine ingredients are generally recognized as safe, or GRAS, while federal health and …
FDA Moves to End Voluntary GRAS System for Food Ingredients Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration last week granted emergency authorization for Zoetis Inc.’s Simparica TRIO to treat New World screwworm infestations in dogs and puppies, expanding …
FDA Authorizes Simparica TRIO for Screwworm in Dogs Read More
WAYNE, PA — Aclaris Therapeutics Inc. (Nasdaq: ACRS) received Fast Track designation from the U.S. Food and Drug Administration for modzatinib as a potential treatment for moderate to severe lichen …
FDA Fast Track Status Advances Aclaris Lichen Planus Drug Read More
PHILADELPHIA, PA — Proscia received a new U.S. Food and Drug Administration 510(k) clearance for its Concentriq AP-Dx digital pathology platform, expanding scanner compatibility and giving the company a regulatory …
Proscia Expands FDA-Cleared Digital Pathology Platform Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration issued an emergency use authorization for Elanco US Inc.’s CLiK Extra wound spray to prevent New World screwworm infestations in multiple …
FDA Authorizes Screwworm Prevention Drug for Livestock, Wildlife Read More