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Results For "design"

1710 News Found

FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers
Drug Approval | September 16, 2025

FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers

Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo


FDA grants Fast Track Designation for Teva’s Emrusolmin
Drug Approval | September 09, 2025

FDA grants Fast Track Designation for Teva’s Emrusolmin

Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development


FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients
Drug Approval | August 18, 2025

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo


AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease
Biotech | August 16, 2025

AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease

The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations


Imfinzi granted Priority Review and Breakthrough Therapy Designation in US
News | July 31, 2025

Imfinzi granted Priority Review and Breakthrough Therapy Designation in US

For patients with resectable early-stage gastric and gastroesophageal junction cancers


Duke Street Bio receives FDA fast track designation for PARP1-selective inhibitor with CNS activity
Biotech | July 08, 2025

Duke Street Bio receives FDA fast track designation for PARP1-selective inhibitor with CNS activity

Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need


Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’
Drug Approval | May 29, 2025

Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’

Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA


Ichnos Glenmark Innovation receives USFDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma
News | May 06, 2025

Ichnos Glenmark Innovation receives USFDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma

IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma


Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS
Drug Approval | January 23, 2025

Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS

The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS


FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections
Drug Approval | January 02, 2025

FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections

MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria