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COVID-19 At-Home Test granted FDA Emergency Use Authorization to expand access to rapid self-testing solutions in the United States – Roche

Written by | 31 Dec 2021

Roche has announced that the FDA has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test. The test uses a simple anterior nasal swab sample that can… read more.

European Commission approves Ronapreve to treat of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation

Written by | 18 Dec 2021

Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) has approved the casirivimab and imdevimab antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in the European… read more.

Moderna provides update on timing of U.S. Emergency Use Authorization of its COVID-19 Vaccine for adolescents

Written by | 4 Nov 2021

Moderna, Inc. provided an update that the FDA has notified the Company that it will require additional time to complete its assessment of Moderna’s Emergency Use Authorization (EUA)… read more.

Pfizer and BioNTech receive first USA emergency use authorization of a COVID 19 vaccine for children ages 5-11

Written by | 3 Nov 2021

Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred… read more.

Moderna announces positive top line data from phase II/III study of COVID-19 vaccine in children 6 to 11

Written by | 31 Oct 2021

-Moderna Inc. announced positive interim data from the Phase II/III study, called the KidCOVE study, of mRNA-1273 , the Company’s vaccine candidate against COVID-19, in children 6 to… read more.

FDA Advisory Committee unanimously votes in support of emergency use for a booster dose of Moderna’s COVID-19 Vaccine in the U.S

Written by | 27 Oct 2021

Moderna, Inc. confirmed that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for a booster dose… read more.

Pfizer and BioNTech receive first FDA Emergency Use Authorization of a COVID-19 vaccine booster

Written by | 20 Oct 2021

Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age… read more.

FDA accepts REGEN-COV for priority review for treatment and prophylaxis of COVID-19 – Regeneron Pharma

Written by | 17 Oct 2021

Regeneron Pharmaceuticals, Inc. has announced that the FDA has accepted for priority review a Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized… read more.

Veklury significantly reduced risk of hospitalization in high-risk patients with COVID-19 – Gilead Sciences

Written by | 4 Oct 2021

Gilead Sciences, Inc. announced positive results from a Phase III randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury(remdesivir) for intravenous… read more.

Johnson & Johnson announces real-world evidence and phase III data confirming strong and long-lasting protection of single-shot COVID-19 vaccine in the U.S.

Written by | 3 Oct 2021

Johnson & Johnson announced new data reinforcing the strong and long-lasting protection of its COVID-19 vaccine . New data also showed that protection against COVID-19 increases when a… read more.

DisCoVeRy trial of Verklury concluded there was no clinical benefit in hospitalised patients with COVID 19 – Gilead Sciences

Written by | 21 Sep 2021

A study conducted in Europe of Gilead’s Verklury (remdesivir) concluded that the antiviral provided no clinical benefit in hospitalized patients with COVID-19 compared to existing treatments . The… read more.

Moderna highlights new clinical data on SpikeVax, its COVID-19 vaccine

Written by | 20 Sep 2021

Moderna, Inc. highlighted a new analysis suggesting that the Moderna COVID-19 vaccine is highly effective against circulating variants of concern , including in a vaccine effectiveness study conducted… read more.

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