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Results For "Fast-Track-Designation"

67 News Found

USFDA grants ILiAD Biotechnologies Fast Track Designation for pertussis vaccine
Biotech | January 04, 2022

USFDA grants ILiAD Biotechnologies Fast Track Designation for pertussis vaccine

BPZE1 is the most advanced next-generation pertussis vaccine currently in clinical development


Lecanemab granted Fast Track designation by the U.S. FDA
Biotech | December 24, 2021

Lecanemab granted Fast Track designation by the U.S. FDA

Alzheimer's disease is a serious, progressive and devastating disease with few treatment options


Teva closes $700M Emalex acquisition
News | June 23, 2026

Teva closes $700M Emalex acquisition

Bolstering neuroscience push with late-stage Tourette therapy


Aragen scales Renaissance Pharma’s cancer antibody to commercial GMP in just 9 months
Biopharma | June 02, 2026

Aragen scales Renaissance Pharma’s cancer antibody to commercial GMP in just 9 months

Anti-GD2 monoclonal antibody for high-risk neuroblastoma advances toward BLA submission following successful tech transfer from California to Bengaluru


Wockhardt wins FDA nod for new antibiotic ZAYNICH against drug-resistant infections
Drug Approval | June 01, 2026

Wockhardt wins FDA nod for new antibiotic ZAYNICH against drug-resistant infections

The approval marks a major milestone in the global fight against antimicrobial resistance


Lilly posts strong early clinical results for one-shot gene-editing cholesterol therapy
Clinical Trials | May 26, 2026

Lilly posts strong early clinical results for one-shot gene-editing cholesterol therapy

A one-shot gene-editing cholesterol therapy could soon be a reality


SN Bioscience doses first patient in global trial of experimental drug for aggressive lung cancer
Clinical Trials | May 19, 2026

SN Bioscience doses first patient in global trial of experimental drug for aggressive lung cancer

The drug also delivered a disease control rate (DCR) of 83.3% in high-dose cohorts and a mean progression-free survival of 6.3 months in SCLC patients


Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke
Clinical Trials | February 07, 2026

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke


iRegene’s Parkinson’s therapy gains FDA designation
News | January 21, 2026

iRegene’s Parkinson’s therapy gains FDA designation

The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases


Gradalis’ Vigil therapy dramatically extends survival in advanced ovarian cancer
Clinical Trials | January 17, 2026

Gradalis’ Vigil therapy dramatically extends survival in advanced ovarian cancer

The randomized, double-blind, placebo-controlled Phase 2b VITAL trial enrolled 91 patients with newly diagnosed Stage IIIb–IV epithelial ovarian cancer