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Fast track (FDA)

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

Savara
Regional

Savara Inc. Launches Early Access Program for Rare Lung Disease Treatment

October 1, 2024September 30, 2024 - by Timothy Alexander

LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has unveiled the Savara Early Access Program, a significant initiative aimed at providing molgramostim to patients suffering from autoimmune pulmonary alveolar proteinosis (aPAP). This …

Savara Inc. Launches Early Access Program for Rare Lung Disease Treatment Read More

Trending News

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  • Pennsylvania Workers Leave More Vacation Time Unused Than Any State in 2025

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