Harmony Biosciences

Harmony Biosciences Secures FDA Orphan Drug Designation for Pitolisant in Prader-Willi Syndrome Treatment

PLYMOUTH MEETING, PA — The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Harmony Biosciences Holdings, Inc.’s (Nasdaq: HRMY) pitolisant for the treatment of Prader-Willi syndrome …

Harmony Biosciences Secures FDA Orphan Drug Designation for Pitolisant in Prader-Willi Syndrome Treatment Read More

Neuraptive Therapeutics

Neuraptive Therapeutics Earns FDA Orphan Drug Designation for Novel Peripheral Nerve Injury Treatment

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

Baudax Bio, Inc.

Baudax Bio Announces Orphan Drug Designation Granted by U.S. FDA for TI-168 for the Treatment of Hemophilia A with Inhibitors

MALVERN, PA — Baudax Bio, Inc. (NASDAQ: BXRX) announced that the U.S. Food and Drug Administration (FDA) recently granted orphan drug designation to its lead clinical candidate TI-168 for the …

Baudax Bio Announces Orphan Drug Designation Granted by U.S. FDA for TI-168 for the Treatment of Hemophilia A with Inhibitors Read More

Marinus Pharmaceuticals

Marinus Pharmaceuticals Receives FDA Orphan Drug Designation for Ganaxolone in the Treatment of Lennox-Gastaut Syndrome

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