The U.S. Food and Drug Administration (FDA) has given approval to start producing ViiV Healthcare’s cabotegavir, the first and only long-acting injectable pre-exposure prophylactic (PrEP) to reduce the risk of sexually acquired HIV-1. HIV-1 affects nearly 38 million...
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...
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...
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...
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