Chester County News and Community Website
RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) recently announced plans to file two New Drug Applications (NDAs) in 2024. The filings, supported by advice from regulatory counsel including former …
NRx Pharmaceuticals Plans to File Two New Drug Applications in 2024 Read More
PLYMOUTH MEETING, PA — Harmony Biosciences (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets. The …
FDA Approves Harmony Biosciences’ WAKIX for Pediatric Narcolepsy Read More
DOYLESTOWN, PA — Aprea Therapeutics, Inc. (Nasdaq: APRE), a clinical-stage biopharmaceutical company, has announced that its Investigational New Drug (IND) application for APR-1051 has been cleared by the U.S. Food …
FDA Greenlights Aprea Therapeutics’ Investigational New Drug Application for Novel Cancer 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 RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage pharmaceutical company, has announced the clearance of its Investigational New Drug Application (IND) by the US Food and Drug Administration …
NRx Pharmaceuticals Secures FDA Clearance for Novel UTI Treatment, Plans Spin-Off Read More
PHILADELPHIA, PA — Vittoria Biotherapeutics has hit a significant milestone with the U.S. Food and Drug Administration (FDA) clearing its Investigational New Drug (IND) application for VIPER-101, the company’s leading …
Vittoria Biotherapeutics Wins FDA Clearance for VIPER-101 in T-Cell Lymphoma, Paving the Way for Innovative CAR-T Therapy Read More
YARDLEY, PA — Optinose (NASDAQ: OPTN), a pharmaceutical company specializing in treatments for ear, nose, and throat conditions, recently announced an extension in the review period of its supplemental new …
Optinose’s XHANCE Review Extended by FDA for Chronic Rhinosinusitis Treatment Read More
BERYWN, PA — In a significant move that promises to reshape the future of pain management, Virpax Pharmaceuticals, Inc. (NASDAQ: VRPX) recently announced its intent to submit an Investigational New …
Virpax Pharmaceuticals’ Envelta Set for Human Trials Following FDA Review: A Potential Game-Changer in Pain Management Read More