Nuvation Bio: FDA Fast Track Designation for NUV-422 Drug
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to NUV-422, a cyclin-dependent kinase (CDK) inhibitor developed by Nuvation Bio. NUV-422 was developed for the treatment of patients with high-grade gliomas, aggressive tumors that can be...
Chinook Therapeutics: Orphan Drug Designation for IgAN
Chinook Therapeutics announced that their drug, atrasentan, has been granted orphan drug designation by the European Commission for the treatment of primary IgA nephropathy (IgAN). The chronic kidney disease (CKD), IgAN, is the most common primary glomerular disease...
Natrunix: FDA Approves XBiotech’s IND Therapy
The US Food and Drug Administration’s (FDA) Division of Rheumatology has authorized the clinical development of XBiotech's Investigational New Drug (IND) Natrunix, a candidate antibody therapy to treat rheumatological diseases. Rheumatological disease, a condition...
FDA Approves Thermo Fisher’s CDx Cancer Tissue Test
The U.S. Food and Drug Administration (FDA) has granted premarket approval for Thermo Fisher's Oncomine Dx Target Test as a companion diagnostic (CDx) developed to help identify non-small cell lung cancer (NSCLC) patients. Lung cancer is the leading cause of cancer...
Aficamten Granted Breakthrough Designation for HCM treatment
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to aficamten, a cardiac myosin inhibitor, for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Hypertrophic cardiomyopathy (HCM) is a condition...
FDA Approves Saol Therapeutics’ LYVISPAH for MS Spasticity
The U.S. Food and Drug Administration (FDA) has approved Saol Therapeutics’ LYVISPAH (baclofen) oral granules for the treatment of spasticity, flexor spasms, concomitant pain, and muscular rigidity resulting from multiple sclerosis (MS). LYVISPAH, as opposed to...
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