Orphan drug: Latest News, Top Stories & Analysis

Medicus Pharma Submits Orphan Drug Application for SkinJect

April 22, 2026April 21, 2026 - by Timothy Alexander

PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) said it submitted an Orphan Drug Designation application to the U.S. Food and Drug Administration for SkinJect (D-MNA) to treat basal cell …

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FDA Bets Big On AI, Animal-Free Testing And High-Tech Cancer Cures

December 7, 2025December 6, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration last week rolled out a sweeping slate of technology, enforcement, and approval actions that touch everything from artificial intelligence inside the …