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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
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
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
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