Harmony Biosciences

Harmony Biosciences Announces US Food & Drug Administration Orphan Drug Designation for Pitolisant for Treatment of Idiopathic Hypersomnia

PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc.  (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) recently granted Orphan Drug designation to pitolisant for the treatment of idiopathic …

Harmony Biosciences Announces US Food & Drug Administration Orphan Drug Designation for Pitolisant for Treatment of Idiopathic Hypersomnia Read More

INOVIO Pharmaceuticals

INOVIO Announces U.S. FDA Breakthrough Therapy Designation Granted for INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis

PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced that the U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation for INO-3107 as a potential treatment for patients with …

INOVIO Announces U.S. FDA Breakthrough Therapy Designation Granted for INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis Read More


Venatorx Pharmaceuticals

FDA Accepts Venatorx Pharmaceuticals’ New Drug Application for Cefepime-Taniborbactam

MALVERN, PA — Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) recenlty accepted the company’s New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic …

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Janssen Pharmaceutical

FDA Approval: AKEEGA, the Game-Changing Dual Action Tablet for BRCA-Positive Metastatic Castration-Resistant Prostate Cancer Treatment

HORSHAM, PA — The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food & Drug Administration (FDA) recently approved AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action …

FDA Approval: AKEEGA, the Game-Changing Dual Action Tablet for BRCA-Positive Metastatic Castration-Resistant Prostate Cancer Treatment Read More