Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced several significant developments this week, spanning advancements in allergy treatment, diabetes management, and Parkinson’s disease therapy, as well …
FDA Takes Action on Allergies, Diabetes, Parkinson’s, and Deadly Food Safety Scare—What You Need to Know Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced its recent approval of Ctexli (chenodiol), marking the first-ever treatment for cerebrotendinous xanthomatosis (CTX), a rare and debilitating …
FDA Breakthrough: First-Ever Treatment Approved for Rare and Devastating CTX Disorder! Read More
PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) has issued a Refusal to File (RTF) letter for its supplemental …
Harmony Biosciences Faces Regulatory Setback, Outlines Future Plans for Pitolisant Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently approved Merilog (insulin-aspart-szjj) as the first rapid-acting insulin biosimilar to Novolog (insulin aspart). This new treatment option, aimed at …
FDA Approves Groundbreaking Rapid-Acting Insulin Biosimilar Merilog, Offering New Hope for Millions Battling Diabetes Read More
PHOENIXVILLE, PA — PleoPharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, the company’s lead investigational asset aimed at mitigating Cannabis …
FDA Grants Fast Track Designation to PleoPharma’s PP-01 for Cannabis Withdrawal Syndrome Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued a safety communication warning users of smartphone-compatible diabetes devices about potential risks stemming from missed or undelivered alerts. …
Stay Alert: FDA Warns Diabetes Patients About Smartphone Device Risks Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved Journavx (suzetrigine) 50 milligram oral tablets, a groundbreaking non-opioid analgesic designed to treat moderate to severe acute pain …
FDA Approves First-in-Class Non-Opioid Pain Drug Journavx Read More
KING OF PRUSSIA, PA — SEED Therapeutics Inc. has announced that its molecular glue therapy, ST-01156, has been granted Rare Pediatric Disease and Orphan Drug designations by the U.S. Food and …
SEED Therapeutics Secures FDA Rare Pediatric and Orphan Drug Designations for ST-01156 Read More
MALVERN, PA — Biopharmaceutical company Ocugen, Inc. (NASDAQ: OCGN) has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for OCU500, a novel …
Ocugen Receives FDA Greenlight for Phase 1 Trial of Mucosal COVID-19 Vaccine Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced the authorization of 20 ZYN nicotine pouch products through its premarket tobacco product application (PMTA) pathway. This landmark …
FDA Grants First Marketing Authorizations for ZYN Nicotine Pouch Products Read More