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Vaccinations using Pfizer/BioNTech’s COVID-19 vaccine are set to begin Sunday throughout Europe, following the European Commission’s landmark authorization of its first coronavirus vaccine. Read More
Novartis has received a Complete Response Letter (CRL) from the FDA regarding a new drug application (NDA) for its cholesterol-lowering drug Leqvio (inclisiran). Read More
The World Health Organization has announced that its COVAX program has now reached supply agreements for almost 2 billion doses of several promising COVID-19 vaccine candidates for distribution to less well-off countries next year. Read More
Oxford University released new trial data last week that raises further questions about the most effective dosing regimen for Oxford’s COVID-19 vaccine candidate, AZD1222, that is being co-developed with AstraZeneca and how it came to pass that two different dosing regimens were pursued. Read More
The FDA has announced that it is investigating multiple reports of allergic reactions to Pfizer/BioNTech’s COVID-19 vaccine as supplies of the shot continue to roll out across the U.S. this week. Read More
The House and Senate are expected to vote today on a combined fiscal 2021 appropriations and COVID-19 relief legislative package after passing another stopgap spending bill Sunday to keep the federal government funded for 24 hours. Read More
The U.S. is set to begin vaccinations of healthcare workers and long-term care facility residents with the nation’s second authorized COVID-19 vaccine today, following the landmark authorization Friday of Moderna’s highly effective shot and its subsequent rollout over the weekend. Read More
GlaxoSmithKline has received FDA approval for Benlysta (belimumab) to treat active lupus nephritis, a serious inflammation of the kidneys that appears in about four in 10 patients with the most common form of lupus. The inflammation can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. Read More