The U.S. Food and Drug Administration (FDA) is encouraging sponsors involved in gene therapy trials to fill data gaps with remote visits and telemedicine. The encouragement comes from Wilson Bryan, the FDA’s OTAT (Office of Tissues and Advanced Therapies) during the...
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Roche for its cobas® SARS-CoV-2 Test. The cobas® SARS-CoV-2 Test is designed to test asymptomatic individuals suspected to have COVID-19. The Center for Disease Control (CDC)...
The U.S. Food and Drug Administration (FDA) authorized ImmunityBio Phase I clinical study for patients with metastatic or locally advanced solid tumors. The study will assess the safety and efficacy of ImmunityBio’s IL-15 superagonist Anktiva (N-803) in...
BD (Becton, Dickinson, and Company) announced today the first self-collection, at-home HPV screening has been CE marked to the IVD directive 98/79/EC. With this new claim, diagnostic labs will now be able to process the self-collected vaginal samples using the BD...
The U.S. Food and Drug Administration (FDA) has granted ZOLL Medical investigational device exemption (IDE) for a randomized study to evaluate TherOx® SuperSaturated Oxygen (SSO2) Therapy in patients with cardiogenic shock and ST Elevation Myocardial Infarction...
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