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Results For "Orphan-Drug"

84 News Found

FDA Granted ODD to Utidelone Injectable from Biostar Pharma for treatment of breast cancer brain metastasis
Drug Approval | April 01, 2024

FDA Granted ODD to Utidelone Injectable from Biostar Pharma for treatment of breast cancer brain metastasis

Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux


USFDA grants ODD to Cevidoplenib for immune thrombocytopenia
News | March 23, 2024

USFDA grants ODD to Cevidoplenib for immune thrombocytopenia

Oscotec has successfully completed phase 2 study in patients with chronic ITP last year


Merck completes acquisition of Harpoon Therapeutics
News | March 12, 2024

Merck completes acquisition of Harpoon Therapeutics

Acquisition broadens oncology pipeline with a portfolio of novel T-cell engagers including HPN328 (MK-6070), an investigational delta-like ligand 3 (DLL3) targeting T-cell engager


Glenmark, Ichnos Sciences form ‘Ichnos Glenmark Innovation’ for new drug discovery in cancer treatment
News | January 30, 2024

Glenmark, Ichnos Sciences form ‘Ichnos Glenmark Innovation’ for new drug discovery in cancer treatment

This alliance brings together drug innovation capabilities of Glenmark and Ichnos to develop cutting-edge therapies for the treatment of hematological malignancies and solid tumors


Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab
News | January 29, 2024

Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab

Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America


Lily announces positive gene therapy result for genetic hearing loss
Clinical Trials | January 25, 2024

Lily announces positive gene therapy result for genetic hearing loss

Hearing restoration was observed within 30 days of a single administration of AK-OTOF in the initial AK-OTOF-101 study participant


European Commission grants ODD to NS-229 for treatment of Eosinophilic Granulomatosis
Clinical Trials | January 23, 2024

European Commission grants ODD to NS-229 for treatment of Eosinophilic Granulomatosis

The orphan drug designation by the EC is issued for drugs which are intended to treat diseases that affect fewer than five in 10,000 people in the European Union


EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome
Drug Approval | January 23, 2024

EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome

GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023


LG Chem initiates phase 2 clinical trials in patients with defects in MC4R pathway causing obesity and hyperphagia
Clinical Trials | October 23, 2023

LG Chem initiates phase 2 clinical trials in patients with defects in MC4R pathway causing obesity and hyperphagia

LG Chem is making progress in the development of the world's first oral treatment for rare forms of obesity.


Zydus to present on ZYIL1 at the International Congress of Parkinson's Disease and Movement Disorders
Clinical Trials | August 28, 2023

Zydus to present on ZYIL1 at the International Congress of Parkinson's Disease and Movement Disorders

In Phase I studies, ZYIL1 was found to be safe and well-tolerated in human volunteers