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U.S. Food and Drug Administration

Science shows that you still need to wear a mask and the vaccines won’t alter your DNA

3 mins read

The FINANCIAL -- With the U.S. Food and Drug Administration announcing emergency use authorization for the Johnson & Johnson single-dose COVID-19 vaccine, UCLA Health experts are continuing to share medically sound, evidence-based information about the safety and effectiveness of all of the vaccines.…

Pfizer and BioNTech Reach Agreement with Covax for Advance Purchase of Vaccine

4 mins read

The FINANCIAL -- Pfizer and BioNTech SE announced an advance purchase agreement with COVAX for up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine. The doses will be delivered throughout 2021.…

Bayer submits marketing authorization applications for finerenone in the U.S. and the EU

2 mins read

The FINANCIAL — Bayer announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval of finerenone for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Finerenone is a first-in-class investigational non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that demonstrated renal and…

Abbott introduces 3D cardiac mapping platform in Europe and Australia

4 mins read

The FINANCIAL — Abbott today announced it has received CE Mark and approval in Australia for its new EnSite™ X EP System, and is launching the system throughout Europe and Australia. The EnSite X System is the only system that offers the option to navigate the cardiac anatomy two different ways on one platform. Abbott sought…

First and only FDA-approved treatment of coronavirus

12 mins read

The FINANCIAL — Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury® (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Previously authorized by the FDA for emergency…