Pharm Exec3d
FDA Grants Fast Track Designation to Adicet Bio’s CAR T-cell Therapy for Systemic Lupus Erythematosus
The FDA has granted Fast Track Designation to Adicet Bio’s ADI-001, an allogeneic gamma delta CAR T-cell therapy, for ...
GlobalData on MSN2d
FDA fast tracks Bracco’s BR55 for Crohn’s disease bowel inflammation detection
Engineered to specifically act on the vascular endothelial growth factor receptor 2 (VEGFR2), BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection claims to i ...
Stockhead on MSN10d
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 ...
Targeted Oncology3d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Targeted Oncology12d
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 ...
Morningstar11d
The FDA Grants Vicore’s Buloxibutid Fast Track Designation for Idiopathic Pulmonary Fibrosis
Vicore plans to leverage the benefits of Fast Track designation which include more frequent communications with FDA as well as the potential for Accelerated Approval and Priority Review.
Adicet Bio granted fast track designation for ADI-001 by FDA
Adicet Bio (ACET) announced the FDA has granted fast track designation to ADI-001 for the potential treatment of adult patients with refractory ...
Adicet Bio Gets Fast Track Designation For ADI-001 In Refractory Systemic Lupus Erythematosus
Adicet Bio, Inc. (ACET), a clinical stage biotechnology company, Wednesday said it received Fast Track Designation from the U.S. Food ...
Medical Design and Outsourcing2d
NIH funds fast-tracked development of fetal hydrocephalus shunt
A team in Pittsburgh received a $2.3 million grant to fast-track the development and clinical transition of a minimally ...
Adelaide Now10d
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 treatment. Alterity shares soared up to 112% this morning after the company ...