FDA Clears VNS Device for Paroxysmal Hemicrania, Hemicrania Continua
Patients treated with gammaCore experienced clinically meaningful benefits.
Patients treated with gammaCore experienced clinically meaningful benefits.
Health care providers should no longer use Medtronic’s Heartware Ventricular Assist Device (HVAD) System in end-stage heart failure patients.
HyperHEP B is the Grifol’s new formulation of its hepatitis B immune globulin.
The approval was based on data from the phase 2/3 OSPREY and phase 3 CONDOR trials that evaluated the diagnostic performance and safety of Pylarify injection.
The EUA was granted based on an interim analysis from the phase 1/2/3 COMET-ICE trial, which evaluated sotrovimab in 583 non-hospitalized adults with mild to moderate COVID-19 at high risk of progression to severe disease.
This action was in response to an executive order issued on August 6, 2020 aimed at protecting the public against outbreaks of emerging diseases and chemical, biological, radiological, and nuclear threats.
The DEA has issued a warning concerning an extortion scam involving calls from someone purporting to be a DEA agent attempting to extort money.
The FDA has approved ReActiv8® (Mainstay Medical), an implantable neurostimulation system, for the treatment of intractable chronic low back.
The first patients have been dosed in a phase 1 trial evaluating a potential antibody therapy designed to treat coronavirus disease 2019. These patients received treatment at major medical centers in the US, including NYU Grossman School of Medicine and Cedars-Sinai in Los Angeles.
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