Chester County News and Community Website
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
The U.S. Food and Drug Administration (FDA) recently alerted the public to its issuance of nine warning letters to various manufacturers and distributors. These companies have allegedly been involved in …
FDA Issues Warning Letters to Nine Companies for Unapproved Antimicrobial Animal Drugs Read More
The U.S. Food and Drug Administration (FDA) has recently shared an important update regarding its efforts to establish a unified Human Foods Program (HFP) and remodel the Office of Regulatory …
FDA Proposes Significant Reorganization to Enhance Oversight of Human Food Supply Read More
In a recent announcement, the U.S. Food and Drug Administration (FDA) revealed its plans to form a new advisory committee dedicated to addressing potential treatments for genetic metabolic diseases. These …
FDA Establishes Specialized Advisory Committee for Genetic Metabolic Diseases Read More
The U.S. Food and Drug Administration (FDA) has recently issued an alert for patients and healthcare providers regarding a safety issue involving the DreamStation 2 Continuous Positive Airway Pressure (CPAP) …
FDA Issues Safety Alert on Philips Respironics’ DreamStation 2 CPAP Machines Due to Overheating Risks Read More
The U.S. Food and Drug Administration (FDA) recently approved Ogsiveo (nirogacestat) tablets for the systemic treatment of adult patients with progressing desmoid tumors, marking it as the first drug to …
FDA Approves Ogsiveo, First-Ever Drug for Treatment of Desmoid Tumors Read More