FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma
Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition
Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition
Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease
Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo
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
Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo
The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations
For patients with resectable early-stage gastric and gastroesophageal junction cancers
Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma
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