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New Drug Application

Traws Pharma
Regional

Traws Targets Stockpile Nod as COVID Drug Outperforms Paxlovid in Trial

January 21, 2026January 19, 2026 - by Timothy Alexander

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

NRx Pharmaceuticals
Regional

NRx Eyes Faster Commercial Path as NRX-101 Moves Into TMS-Enhanced Depression Treatment

December 9, 2025December 7, 2025 - by Timothy Alexander

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
NRx Pharmaceuticals
Regional

NRx’s Preservative-Free Ketamine Reaches FDA Review as Company Targets 2026 Launch

December 8, 2025December 7, 2025 - by Timothy Alexander

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

Johnson & Johnson
Regional

Johnson & Johnson Seeks FDA Approval for First Oral IL‑23 Inhibitor to Treat Plaque Psoriasis

July 24, 2025July 23, 2025 - by Timothy Alexander

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
Harmony Biosciences
Regional

Harmony Biosciences Faces Regulatory Setback, Outlines Future Plans for Pitolisant

February 20, 2025February 19, 2025 - by Timothy Alexander

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

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