Chester County News and Community Website
YARDLEY, PA — The U.S. Food and Drug Administration (FDA) recently approved XHANCE® (fluticasone propionate) nasal spray, developed by Optinose (NASDAQ: OPTN), for the treatment of chronic rhinosinusitis without nasal …
FDA Approves Optinose’s XHANCE as First Treatment for Sinusitis Without Nasal Polyps Read More
CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc., a Montgomery County-based biopharmaceutical company, has received accelerated approval from the U.S. Food and Drug Administration (FDA) for Rezdiffra. This game-changing medication, used in …
Landmark FDA Approval of Rezdiffra Marks New Era for NASH Treatment Read More
MALVERN, PA — Venatorx Pharmaceuticals and Melinta Therapeutics recently received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning their New Drug Application (NDA) for …
FDA Requests Additional Data for Venatorx and Melinta’s Antibiotic Combination Read More
PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) has announced that the U.S. Food and Drug Administration (FDA) has granted priority review to its supplemental New Drug Application …
Harmony Biosciences’ Narcolepsy Drug for Children Gets FDA Priority Review Read More
HORSHAM, PA — Johnson & Johnson recently announced that the U.S. Food and Drug Administration (FDA) has granted approval for a reduced dosage frequency of its drug TECVAYLI® (teclistamab-cqyv) in …
FDA Greenlights Reduced Dosing Frequency for Johnson & Johnson’s TECVAYLI Read More
NEWTOWN, PA — Helius Medical Technologies, Inc., a prominent player in the healthcare technology sector, has announced a significant stride towards revolutionizing stroke therapy. The company has concluded negotiations with …
Helius Medical Technologies Advances Stroke Program with FDA Approval Read More
PHILADELPHIA, PA — The biotech firm Cabaletta Bio, Inc. (Nasdaq: CABA) has secured an Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its investigational therapy, …
FDA Awards Orphan Drug Designation to Cabaletta’s Innovative Myositis Therapy Read More
WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) has achieved a significant milestone in its commercial strategy. The Centers for Medicare & Medicaid Services (CMS) has issued a permanent …
Verrica Pharmaceuticals Earns Key CMS Approval, Streamlining Access to Molluscum Contagiosum Treatment Read More
WILMINGTON, DE — Pharmaceutical giant AstraZeneca has announced the commercial availability of AIRSUPRA® (albuterol/budesonide) in the United States, marking a significant step forward in asthma treatment. The FDA approved AIRSUPRA …
AstraZeneca Rolls Out AIRSUPRA, a Novel Combination Therapy for Asthma Read More
WAYNE, PA — Neuraptive Therapeutics Inc. recently announced that its novel treatment for peripheral nerve injury, NTX-001, has received Orphan Drug Designation from the United States Food and Drug Administration …
Neuraptive Therapeutics Earns FDA Orphan Drug Designation for Novel Peripheral Nerve Injury Treatment Read More