Chester County News and Community Website
WILMINGTON, DE — Prelude Therapeutics Incorporated (Nasdaq: PRLD) said the U.S. Food and Drug Administration has cleared its investigational new drug application for PRT12396, allowing the company to begin a …
FDA Clears Prelude’s Experimental Cancer Drug, Opening New Path for Blood Disorders Read More
NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) said it has taken a key step toward federal preparedness planning by filing an investigational new drug application for its influenza candidate …
Traws Targets Stockpile Nod as COVID Drug Outperforms Paxlovid in Trial Read More
WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) expanded its development plan for NRX-101, amending its Investigational New Drug application to study the drug in combination with Transcranial Magnetic Stimulation …
NRx Eyes Faster Commercial Path as NRX-101 Moves Into TMS-Enhanced Depression Treatment Read More WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) said the U.S. Food and Drug Administration has accepted its Abbreviated New Drug Application for KETAFREE, a preservative-free intravenous ketamine product that …
NRx’s Preservative-Free Ketamine Reaches FDA Review as Company Targets 2026 Launch Read More
SPRING HOUSE, PA — Johnson & Johnson has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for icotrokinra, a once-daily oral peptide therapy targeting the …
Johnson & Johnson Seeks FDA Approval for First Oral IL‑23 Inhibitor to Treat Plaque Psoriasis Read More
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