Chester County News and Community Website
PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) has issued a Refusal to File (RTF) letter for its supplemental …
Harmony Biosciences Faces Regulatory Setback, Outlines Future Plans for Pitolisant Read More
WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) announced that its partner, Torii Pharmaceutical Co. Ltd., has submitted a New Drug Application (NDA) in Japan for TO-208, a cantharidin-based …
New Drug Application Submitted in Japan for Verrica Pharmaceuticals’ TO-208 Read More
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
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