Chester County News and Community Website
SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) secured U.S. Food and Drug Administration approval for IMAAVY to treat warm autoimmune hemolytic anemia in patients 12 and older who …
FDA Clears J&J’s IMAAVY as First Drug for Rare Blood Disease Read More
WASHINGTON, D.C. — The Food and Drug Administration approved Takeda Pharmaceuticals America Inc.’s Mimrylo for adults with polycythemia vera whose disease is not adequately controlled with existing therapy, introducing a …
FDA Approves Mimrylo to Cut Phlebotomy Need in Blood Disorder Read More
WASHINGTON, D.C. — The Food and Drug Administration approved Priovant Therapeutics Inc.’s Lisraya for adults with dermatomyositis, providing an oral treatment for the rare autoimmune disease after a Phase 3 …
FDA Approves Lisraya as Oral Treatment for Dermatomyositis Read More
WASHINGTON, D.C. — The Food and Drug Administration authorized emergency use of Bimectin ivermectin injections to prevent New World screwworm infestations in certain cattle, expanding the number of available drugs …
FDA Authorizes Generic Ivermectin to Protect Cattle From Screwworm Read More
WASHINGTON, D.C. — The Food and Drug Administration approved Revolution Medicines Inc.’s Rasonque for certain adults with metastatic pancreatic adenocarcinoma after a clinical trial showed the drug nearly doubled median …
FDA Approves Rasonque as Pancreatic Cancer Treatment Read More
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