Chester County News and Community Website
SPRING HOUSE, PA — Johnson & Johnson announced it recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for TREMFYA® (guselkumab). This application …
Johnson & Johnson Seeks FDA Approval for New Ulcerative Colitis Treatment Read More
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
BERWYN, PA — In a move to promote diversity in clinical trials, Chester County-based Mural Health has announced the “Harley Jacobsen Clinical Trial Participation Income Exemption Act,” a landmark legislation …
Mural Health Champions Revolutionary Bill for Enhanced Diversity in Clinical Trials 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
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