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News about "Fast Track Designation"
LEO Pharma has agreed to acquire worldwide rights to Tanabe Pharma’s oral MC1R agonist dersimelagon for up to USD 435 million in upfront and near-term milestones, strengthening its rare dermatology pipeline for EPP and XLP.
Fast Track Designation | 19/08/2026 | By News Bureau
BioInvent's BI-1808 Receives FDA Fast Track Designation for Ovarian Cancer
BioInvent’s BI-1808 has received FDA Fast Track Designation for ovarian cancer, supporting accelerated development of the investigational anti-TNFR2 therapy in combination with pembrolizumab.
Fast Track Designation | 11/08/2026 | By News Bureau
Lundbeck's Oral Narcolepsy Drug Candidate Receives FDA Fast Track Designation
Lundbeck has received FDA Fast Track designation for Lu AH69593, its investigational oral orexin 2 receptor agonist, accelerating the development of a potential new treatment for patients living with narcolepsy.
Fast Track Designation | 27/07/2026 | By News Bureau
OKYO Pharma Receives FDA Support to Advance Urcosimod into Global Phase 3 Trial
Positive feedback from the US FDA has reinforced OKYO Pharma's clinical development strategy for urcosimod, with the company preparing to launch a global Phase 3 trial for neuropathic corneal pain, a debilitating eye disorder that currently lacks FDA-approved therapies.
Fast Track Designation | 13/07/2026 | By News Bureau | 114
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 | 100
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 | 181
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 | 168
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 | 315
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 | 382
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 | 403
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