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Pamrevlumab (INN; [1] development code FG-3019) is a humanized monoclonal antibody designed for the treatment of idiopathic pulmonary fibrosis and pancreatic cancer. It binds to the connective tissue growth factor (CTGF) protein. [2] This drug was developed by FibroGen, Inc. [3]
Garadacimab is an experimental human monoclonal antibody under investigation for the treatment of hereditary angioedema. [1] Garadacimab is a monoclonal antibody against the activated coagulation factor XIIa (FXIIa), with potential anti-inflammatory and anticoagulant activities.
When used as drugs, the International Nonproprietary Names (INNs) end in -mab. The remaining syllables of the INNs, as well as the column Source, are explained in Nomenclature of monoclonal antibodies. Types of monoclonal antibodies with other structures than naturally occurring antibodies.
Orphan drug status, which is given to drugs meant for the treatment of rare diseases, offers drug developers a path to faster approval and enhanced market exclusivity. So let's look at a small ...
BioMarin Pharmaceuticals (NAS: BMRN) keeps chugging along, pushing its orphan drug pipeline forward. Yesterday, the biotech announced data from two trials, giving the company confidence to move ...
The U.S. Food and Drug Administration (FDA) granted orphan drug designations in 2010 and 2020, [9] [10] and breakthrough therapy designation in 2016, on the basis of preliminary data from the phase II trial.
Tocilizumab, sold under the brand name Actemra among others, is an immunosuppressive drug, used for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, COVID‑19, and systemic sclerosis-associated interstitial lung disease (SSc-ILD).
In January 2018, the drug's rights were transferred to Celgene with their purchase of Impact Biomedicines. [9] Fedratinib was approved for medical use in the United States in August 2019. [2] [5] [6] The U.S. Food and Drug Administration (FDA) granted the application for fedratinib priority review and orphan drug designations. [5]