Chester County News and Community Website
PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) announced this week that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designations to its investigational therapy, CABA-201.
Cabaletta Bio Fast-Tracks Potential Autoimmune Breakthrough Read More
The U.S. Food and Drug Administration (FDA) recently authorized Florida’s Agency for Health Care Administration to import certain prescription drugs from Canada under section 804 of the Federal Food, Drug, …
Florida Gets Green Light from FDA to Import Prescription Drugs from Canada: A Potential Game-Changer for U.S. Healthcare Costs Read More
Federal authorities are urgently warning consumers not to eat, sell, or serve multiple brands of apple cinnamon fruit pouches due to an ongoing investigation into elevated lead levels. The Food …
Warning Issued Over Elevated Lead Levels in Recalled Apple Cinnamon Fruit Pouches Read More
PLYMOUTH MEETING, PA — Biotechnology firm INOVIO (NASDAQ: INO) recently announced plans to submit a Biologics License Application (BLA) for its innovative DNA medicine, INO-3107, potentially paving the way for …
INOVIO Eyes Accelerated Approval for Groundbreaking DNA Medicine INO-3107 Read More
WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) has announced that it received the minutes from its recent Type C meeting with the U.S. Food and Drug Administration (FDA). …
Verrica Pharmaceuticals Gains FDA Alignment for YCANTH’s Phase 3 Clinical Development Plan Read More
MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company, recently announced that it has received alignment from the U.S. Food and Drug Administration (FDA) on the design of a …
Ocugen Gains FDA Alignment for Phase 3 Trial of Retinitis Pigmentosa Treatment Read More MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN), a Pennsylvania-based biopharmaceutical company, has scored a significant regulatory milestone this week with the U.S. Food and Drug Administration (FDA) granting Regenerative Medicine …
Ocugen’s OCU400 Earns FDA’s RMAT Designation, Enhancing Prospects for Retinitis Pigmentosa Treatment Read More
MALVERN, PA — Neuronetics, Inc. (NASDAQ: STIM) this week announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of its NeuroSite™ Coil Placement Accessory. The state-of-the-art tool, designed to …
Neuronetics Secures FDA Clearance for NeuroSite, Streamlining Mental Health Treatments Read More
The FDA announced that the U.S. District Court for the District of Massachusetts recently issued a consent decree of permanent injunction against the Pharmasol Corporation, a Massachusetts-based company, and its …
U.S. Court Orders Pharmasol Corporation to Halt Drug Distribution Over FD&C Act Violations Read More
The U.S. Food and Drug Administration (FDA), in a joint operation with U.S. Customs and Border Protection (CBP), has announced the recent seizure of approximately 1.4 million units of unauthorized …
FDA and CBP Seize Over 1.4 Million Units of Unauthorized E-Cigarettes in Joint Operation Read More