News about "Fast Track Designation"

Rznomics Secures US FDA RMAT Designation for Liver Cancer Gene Therapy Candidate RZ-001

The FDA has granted Regenerative Medicine Advanced Therapy designation to RZ-001, an RNA-based gene therapeutic for hepatocellular carcinoma, accelerating its clinical development and regulatory review pathway.

Fast Track Designation | 11/05/2026 | By News Bureau

Thryv Therapeutics Advances THRV-1268 Programme with Phase II/III Trial and FDA Fast Track Status

Thryv Therapeutics initiates Phase II/III clinical testing and secures FDA Fast Track status for THRV-1268, advancing a potential first-in-class therapy for Long QT Syndrome.

Fast Track Designation | 27/04/2026 | By News Bureau

Diamyd Medical Advances Type I Diabetes Phase III Efficacy Readout by Nine Months

Diamyd Medical has aligned with the US FDA to accelerate the primary efficacy readout of its Phase 3 DIAGNODE-III trial in type 1 diabetes from 24 to 15 months, enabling results to be available nine months earlier than previously planned.

Fast Track Designation | 30/12/2025 | By News Bureau |  139

US FDA Grants Fast Track Designation to AAV Gene Therapy by Sanofi

The US FDA has granted fast track designation to Sanofi’s SAR446268, an AAV gene therapy for juvenile and adult-onset myotonic dystrophy type 1 (DM1).

Fast Track Designation | 23/09/2025 | By Dineshwori |  263

Innovent Gets Second Fast Track Designation from FDA for IBI363

This designation applies to the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immune checkpoint inhibitor therapy and platinum-based chemotherapy.

Fast Track Designation | 17/02/2025 | By Aishwarya |  337

Johnson & Johnson Receives FDA Fast Track Designations for Treatment of Alzheimer's Disease

Posdinemab is the second Fast Track designation granted in 2024 for the Company’s AD portfolio.

Fast Track Designation | 10/01/2025 | By Aishwarya |  375

Phanes Secures Fast Track Designation for PT217 from FDA

PT217, a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47, is being developed for the treatment of patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma, including neuroendocrine prostate cancer (NEPC).

Fast Track Designation | 05/12/2024 | By Aishwarya |  355

Sun Pharma and Moebius Medical Receive FTD for MM-II for Treatment of Osteoarthritis Knee Pain

Sun Pharma and Moebius Medical have announced that the US Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to MM-II (Large Liposomes of DPPC and DMPC) for the treatment of osteoarthritis knee pain.

Fast Track Designation | 07/09/2024 | By Aishwarya |  326

Innovent Secures Fast Track Designation from FDA for IBI363

Innovent Biologics has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to its PD-1/IL-2α Bispecific Antibody Fusion Protein for the treatment of unresectable locally advanced or metastatic melanoma.

Fast Track Designation | 04/09/2024 | By Aishwarya |  696

Clarity Secures FDA Fast Track Designation for 64Cu-SAR-bisPSMA

Clarity Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions.

Fast Track Designation | 23/08/2024 | By Aishwarya |  275