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Health Check: Alterity angles for fast-track FDA approval after positive trial results tackling Parkinson’s-like disorder
Following “positive” top-line phase II trial results, neurodegenerative disease house Alterity Therapeutics (ASX:ATH) will ...
ophthalmologytimes7d
FDA grants fast track designation to N-acetylcysteine amide tablets from Nacuity Pharmaceuticals
The NPI-001 (N-acetylcysteine amide) tablets are a proprietary investigational therapy for the treatment of patients with ...
Solid Biosciences Receives FDA Fast Track Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia
Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation ...
Targeted Oncology12d
FDA Grants Fast Track Designation to LOAd703 in Pancreatic Cancer
LOAd703, an oncolytic adenovirus with transgenes for 4-1BBL and TMZ-CD40L, has received FDA fast track designation for ...
Targeted Oncology2d
FDA Grants FTD to 64Cu-SAR-bisPSMA for PET Imaging in Prostate Cancer
The FDA granted fast track designation to 64Cu-SAR-bisPSMA for PET imaging of PSMA-positive prostate cancer lesions in ...
Business Insider9d
Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1
The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the goal of getting important new ...
Healio8d
FDA grants fast-track designation to myotonic dystrophy type 1 treatment
The FDA has granted fast-track designation to an investigational antisense oligonucleotide to treat individuals with myotonic ...
Dyne Gets FDA Fast-Track Status for Neuromuscular Product Candidate
Dyne Therapeutics received fast-track designation from the Food and Drug Administration for a treatment of myotonic dystrophy type 1, a neuromuscular disease.
Life Molecular Imaging Secures FDA Fast Track Designation for [18F]Florbetaben in Diagnosing Cardiac AL and ATTR Amyloidosis
Life Molecular Imaging (LMI), an international pharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging, announces that the U.S. Food and ...
Solid Biosciences' Ataxia Treatment Receives FDA Fast-Track Designation
Fast-track status will allow Solid Biosciences to have more frequent meetings with the FDA throughout the treatment-development process and, potentially, get the product to patients faster than would ...
Yahoo Finance9d
Solid Biosciences Receives FDA Fast Track Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia
Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation - CHARLESTOWN, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE ...
Morningstar9d
Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1
The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the goal of getting important ...