Chester County News and Community Website
WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) said it remains on track to submit a New Drug Application in the second half of 2026 for QTORIN rapamycin after reporting …
Palvella Eyes 2027 Launch After Positive Phase 3 Results Read More
RADNOR, PA — Mineralys Therapeutics Inc. (Nasdaq: MLYS) reported its fourth-quarter and full-year 2025 financial results and said the U.S. Food and Drug Administration has accepted its new drug application …
Mineralys Reports 2025 Results, Advances Hypertension Drug Review Read More WAYNE, PA — Palvella Therapeutics Inc. (Nasdaq: PVLA) said it achieved the primary and all secondary endpoints in a Phase 3 trial of QTORIN 3.9% rapamycin gel for microcystic lymphatic …
Palvella Reports Phase 3 Success for QTORIN in Rare Skin Disorder Read More
MALVERN, PA — NexEos Bio Vision Health said that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to begin a Phase II/III clinical trial of …
NexEos Bio Vision Health Wins FDA Clearance for NTX-1024 Trial Read More
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