GlaxoSmithKline, MacroGenics Inc. and More Receive FDA Approvals
The U.S. Food and Drug Administration (FDA) had many approvals this week including a treatment created by GlaxSmithKline for Lupus Nephritis in adults, one of the most common autoimmune diseases. The FDA approval for GlaxoSmithKline was historic, as Benlysta is the...
Jet 7 Xtra Flex Catheter for Stroke Patients Recalled by Penumbra
Following the close of the market on Tuesday, Penumbra announced the U.S. Food and Drug Administration (FDA) advised recall of their catheter device resulting from 14 reported patient deaths, among other patient hemorrhages,...
Emergency Use Authorization Given to Ellume’s At-Home COVID-19 Test
On December 15, 2020, the U.S. Food and Drug Administration (FDA) approved the first over the counter fully at-home COVID-19 Test. The test delivers results in approximately 20 minutes and diagnoses individuals as young as two years old and is expected to be delivered...
Pre-Market Review Option Rolled Out by FDA for 510k Clearance
Under its Abbreviated 510k Program, the U.S. Food and Drug Administration (FDA) outlined guidelines for the Safety and Performance Based Pathway, a fast track for medical devices in well established categories to gain market...
Pfizer and BioNTech Receive Premier COVID-19 Vaccine Authorization
Pfizer and BioNTech have made history with their COVID-19 vaccine, as it is the first to enter the U.S. market after Phase 3 clinical trial results showing 95% efficacy. The mRNA vaccine is being allocated for emergency use to hospitals nationwide,...
AstraZeneca Partners with Sputnik to Boost COVID-19 Vaccine Efficacy
Russia’s Sovereign Health Plan disclosed today (12/11) that Sputnik-V will be joining AstraZeneca in their pursuit for a COVID-19 vaccine. The joint vaccine production will enter clinical trial phases on adults 18 years and older by the...