Chester County News and Community Website
RADNOR, PA — Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) announced that the U.S. Food and Drug Administration (FDA) recently granted orphan drug designation (ODD) to ganaxolone for the treatment of Lennox-Gastaut …
Marinus Pharmaceuticals Receives FDA Orphan Drug Designation for Ganaxolone in the Treatment of Lennox-Gastaut Syndrome Read More
PHILADELPHIA, PA — Amicus Therapeutics (Nasdaq: FOLD) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently adopted a positive opinion recommending …
Amicus Therapeutics Receives Positive CHMP Opinion for Pombiliti Read More
MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) announced that the FDA recently granted orphan drug designations to OCU400—human nuclear hormone receptor subfamily 2 group E member 3 (hNR2E3)—for the treatment …
Ocugen Announces OCU400 Receives Orphan Drug Designations for Retinitis Pigmentosa and Leber Congenital Amaurosis Read More
DEVON, PA — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) announced that the European Commission (EC) recently granted orphan drug designation to cannabidiol, the active ingredient in its transdermal gel, Zygel™, for …
Zynerba Pharmaceuticals Receives Orphan Drug Designation from European Commission Read More
DOYLESTOWN, PA — Antengene Corporation Limited (SEHK: 6996.HK) announced that ATG-101, the company’s in-house developed novel PD-L1/4-1BB bispecific antibody, was recently granted an Orphan Drug Designation (ODD) by the U.S. …
Antengene Announces ATG-101 Granted Orphan Drug Designation by the U.S. FDA Read More
BERWYN, PA — Panavance Therapeutics Inc. announced the U.S. Food and Drug Administration (FDA) recently granted Orphan Drug Designation to GP-2250 for the treatment of all forms of pancreatic cancer.
Panavance Therapeutics Announces Orphan Drug Designation for GP-2250 Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of …
FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy Read More