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September 09, 2025 08:30 ET | Source: Teva Pharmaceutical Industries Ltd

Teva’s Emrusolmin Granted U.S. FDA Fast Track Designation for Treatment of Multiple System Atrophy

Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development.New...
August 28, 2025 05:00 ET | Source: TOLREMO Therapeutics

TOLREMO therapeutics Receives Two FDA Fast Track Designations for TT125-802 in Pretreated, Advanced or Metastatic NSCLC With Either an EGFR or a KRAS-G12C Mutation

TT125-802 is a small molecule CBP/p300 bromodomain inhibitor that shows clinical activity as single agent in solid tumors, including advanced EGFR-mutated and KRAS-G12C-mutated non-small cell lung...
May 05, 2025 07:00 ET | Source: IGI, Inc.

Ichnos Glenmark Innovation (IGI) Receives U.S. FDA Fast Track Designation for ISB 2001 for Relapsed/Refractory Multiple Myeloma

IGI, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ISB 2001.
February 20, 2025 08:30 ET | Source: BioRestorative Therapies, Inc

BioRestorative Receives FDA Fast Track Designation for BRTX-100 Chronic Lumbar Disc Disease Program

– Underscores high unmet need for a therapeutic alternative to opioids and surgical interventions – – Reflects positive preliminary Phase 2 Safety and Efficacy data reported to date – – May also...
December 19, 2024 07:00 ET | Source: Nurix Therapeutics, Inc.

Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory Waldenstrom’s Macroglobulinemia

SAN FRANCISCO, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat...
October 29, 2024 10:00 ET | Source: Longeveron

Longeveron® Presents Lomecel-B™ Data for Alzheimer’s Disease Indication in Late Breaking Poster Presentation at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24)

Longeveron presents clinical data for stem cell therapy in Alzheimer's disease. Findings offer potential mechanistic and clinical insights.
July 17, 2024 08:00 ET | Source: Longeveron

Longeveron® Announces U.S. FDA Grants Fast Track Designation for Lomecel-B™ for the Treatment of Mild Alzheimer’s Disease

Longeveron announces FDA has granted Fast Track designation to cellular therapy Lomecel-B(TM) for the treatment of mild Alzheimer’s Disease.
June 24, 2024 06:45 ET | Source: BioNTech SE

BioNTech und DualityBio erhalten Fast-Track-Status der FDA für Antikörper-Wirkstoff-Konjugat-Kandidat BNT324/DB-1311 bei Prostatakrebs

Der Status basiert auf präklinischen Daten und Daten aus einer laufenden Phase-1/2-Studie für BNT324/DB-1311; vorläufige klinische Phase-1/2-Daten zeigten eine Anti-Tumor-Aktivität und ein...
June 24, 2024 06:45 ET | Source: BioNTech SE

BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer

Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with antitumor activity and a manageable safety profile demonstrated by preliminary Phase 1/2...
June 11, 2024 08:45 ET | Source: FN Media Group LLC

Global Multiple Sclerosis Drugs Market Size Projected to Reach $38 Billion By 2032 as Demand on R&D for Developing Innovative Drugs Rises

PALM BEACH, Fla., June 11, 2024 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - In the last twenty years, the amount of people with multiple sclerosis (MS) in the United States has more than...