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Results For "Fast-Track-Designation"

61 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


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


Complement Therapeutics’ gene therapy gains FDA fast-track for vision loss treatment
Biotech | January 12, 2026

Complement Therapeutics’ gene therapy gains FDA fast-track for vision loss treatment

CTx001 targets Geographic Atrophy (GA) secondary to Age-related Macular Degeneration


Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy
R&D | January 08, 2026

Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy

The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production


Medera doses final patient in high-dose HFpEF gene therapy trial
Biopharma | January 07, 2026

Medera doses final patient in high-dose HFpEF gene therapy trial

Heart failure affects an estimated 64.3 million people worldwide


Diamyd Medical accelerates Phase 3 Type 1 diabetes trial following FDA guidance
Clinical Trials | December 31, 2025

Diamyd Medical accelerates Phase 3 Type 1 diabetes trial following FDA guidance

The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026


Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus
Clinical Trials | December 21, 2025

Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus

The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation


Merck unveils first human data for Alzheimer’s candidates
Clinical Trials | December 03, 2025

Merck unveils first human data for Alzheimer’s candidates

The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration