Stockhead on MSN6h
Health Check: Alterity angles for fast-track FDA approval after positive trial results tackling Parkinson’s-like disorder
Alterity plans to seek US FDA fast-track approval after posting positive phase II results for multiple system atrophy ...
Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides a Corporate Update
Reported a robust objective response rate of 75.5% from the Phase 1 study of NX-5948 in patients with relapsed/refractory CLL/SLL at the 66th American Society of Hematology Annual Meeting Received ...
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 ...
Erasca's Naporafenib Is Shaping Up Nicely For NRASm Melanoma
Naporafenib is Erasca’s main candidate, and it has Fast Track status for NRASm melanoma. See why I rate ERAS stock as a buy.
Clarity Pharmaceuticals: Clarity receives U.S. FDA Fast Track Designation for Cu-64 SAR-bisPSMA in biochemical recurrence of prostate cancer
Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to ...
ophthalmologytimes6d
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 ...
Healio7d
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 ...
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 gets FDA Fast Track for FA gene therapy
CHARLESTOWN, Mass. - Solid Biosciences Inc. (NASDAQ:SLDB), a $130.65 million market cap biotechnology company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) ...
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 ...
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 ...