Biopharmaceutical company, Intra-Cellular Therapies, has announced U.S. Food and Drug Administration (FDA) approval of CAPLYTA to treat bipolar I and bipolar II disorders. Bipolar is a mental disorder characterized by unusual mood swings, energy levels, and...
The U.S. Food and Drug Administration (FDA) has accepted Rakuten Medical’s, Inc. application for to begin clinical studies of the company’s investigational new drug (IND) for patients with advanced squamous cell carcinoma or patients with neck and head squamous cell...
In a potential development for clinical trial translations to come, the U.S. Food and Drug Administration (FDA) authorized orphan drug designation (ODD) to Nkarta’s engineered natural killer (NK) cell therapy NKX101 for the treatment of acute myeloid leukemia (AML)....
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 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...
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...
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...
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...
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...
The China National Medical Products Administration (NMPA) has approved SYLVANT (siltuximab for injection) for the treatment of patients with multicentric Castleman disease (MCD), BeiGene Ltd. and EUSA Pharma Ltd today announced. MCD is known as a lymphoproliferative...
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