Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved three new color additives derived from natural sources, marking a significant development in the effort to phase out …
FDA Approves Three New Natural Color Additives, Advances Initiative to Remove Petroleum-Based Dyes Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has unveiled a historic initiative to implement artificial intelligence (AI) technologies agency-wide, with a target completion date of June 30, …
FDA Announces Ambitious AI Expansion to Streamline Scientific Reviews Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced its plan to increase the use of unannounced inspections at foreign facilities producing foods, essential medicines, and medical …
FDA Tightens Oversight with Expanded Unannounced Inspections at Foreign Manufacturing Facilities Read More
WAYNE, PA — Teleflex Incorporated (NYSE: TFX) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Indications for Use of its QuikClot Control+™ Hemostatic …
Teleflex Announces FDA Clearance for Expanded Use of QuikClot Control+ Hemostatic Device Read More
SPRING HOUSE, PA — On Wednesday, the U.S. Food and Drug Administration (FDA) granted approval for IMAAVY™ (nipocalimab-aahu), Johnson & Johnson’s cutting-edge FcRn-blocking antibody treatment for generalized myasthenia gravis (gMG). …
FDA Approves Johnson & Johnson’s IMAAVY for Generalized Myasthenia Gravis Read More
NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has received FDA approval to move forward with its Virtue Trial, a pivotal clinical study designed to evaluate its next-generation …
Orchestra BioMed Secures FDA Clearance for Virtue Trial to Advance Coronary ISR Treatment Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) recently unveiled comprehensive plans to eliminate petroleum-based synthetic dyes from the …
ICYMI: FDA Declares War on Toxic Food Dyes in Bold Move to Protect Kids’ Health Read More NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) announced that its atrioventricular interval modulation (AVIM) therapy has received Breakthrough Device Designation (BDD) from the U.S. Food and Drug …
Orchestra BioMed Secures FDA Breakthrough Device Designation for AVIM Therapy Read More
WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS) has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ATI-052, a bispecific …
Aclaris Therapeutics Secures FDA Clearance for ATI-052 Clinical Trial Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced a new policy directive to limit employees of FDA-regulated companies, such as pharmaceutical firms, from serving as official …
FDA Implements New Policy to Restrict Industry Ties on Advisory Committees Read More