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Fast track (FDA)

Aclaris Therapeutics
Health / Medical

FDA Fast Track Status Advances Aclaris Lichen Planus Drug

August 13, 2026August 11, 2026 - by Timothy Alexander

WAYNE, PA — Aclaris Therapeutics Inc. (Nasdaq: ACRS) received Fast Track designation from the U.S. Food and Drug Administration for modzatinib as a potential treatment for moderate to severe lichen …

FDA Fast Track Status Advances Aclaris Lichen Planus Drug Read More

Arbutus Biopharma
Regional

Arbutus Drug Candidate Receives FDA Fast Track Designation

April 22, 2026April 20, 2026 - by Timothy Alexander

WARMINSTER, PA — Arbutus Biopharma Corporation (Nasdaq: ABUS) announced that the U.S. Food and Drug Administration has granted Fast Track designation to its drug candidate imdusiran for the treatment of …

Arbutus Drug Candidate Receives FDA Fast Track Designation Read More
Palvella Therapeutics
Research

FDA Fast Track Puts Palvella’s Rare Skin Drug on a Faster Regulatory Path

December 23, 2025December 22, 2025 - by Timothy Alexander

WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) said the U.S. Food and Drug Administration has granted Fast Track designation to QTORIN™ rapamycin for the treatment of angiokeratomas, a rare …

FDA Fast Track Puts Palvella’s Rare Skin Drug on a Faster Regulatory Path Read More

U.S. Food and Drug Administration
Health / Medical / National

FDA’s Week of Breakthroughs: New Gene Therapy, New Antibiotics, New Rules

December 14, 2025December 14, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration rolled out a rapid-fire series of moves this month that could reshape how Americans manage chronic disease, treat rare and life-threatening blood …

FDA’s Week of Breakthroughs: New Gene Therapy, New Antibiotics, New Rules Read More
PleoPharma
Research

FDA Grants Fast Track Designation to PleoPharma’s PP-01 for Cannabis Withdrawal Syndrome

February 15, 2025February 14, 2025 - by Timothy Alexander

PHOENIXVILLE, PA — PleoPharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, the company’s lead investigational asset aimed at mitigating Cannabis …

FDA Grants Fast Track Designation to PleoPharma’s PP-01 for Cannabis Withdrawal Syndrome Read More

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