Chester County News and Community Website
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
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
RADNOR, PA — In a significant development that could revolutionize the treatment of complicated urinary tract infections (cUTI) and pyelonephritis, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has received Qualified Infectious Disease …
NRx Pharmaceuticals’ NRX-101 Receives FDA Fast Track Designation: A Potential Gamechanger for Treating Complex UTIs Read More
WASHINGTON, D.C. — In a series of announcements last week, the U.S. Food and Drug Administration (FDA) showcased its broad range of responsibilities, from food safety to advancing medical technology …
FDA’s Week of Innovation: Scallops Alert, AI Health Challenge Winners, Digital Health Equity & Novel Drug Approvals Read More 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