Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.
The device is attached to the top of the canister of the patient’s inhaler and works together with the mobile app to monitor and provide feedback.
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.