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New Drug Application

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
Verrica Pharmaceuticals Inc
Products and Services

New Drug Application Submitted in Japan for Verrica Pharmaceuticals’ TO-208

December 7, 2024December 6, 2024 - by Timothy Alexander

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

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