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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.

Analyses published in NEJM of a third booster shot of the Comirnaty messenger RNA vaccine from Pfizer

Written by | 19 Sep 2021

Publication of two separate analyses in The New England Journal of Medicine comes before a meeting of FDA advisers to discuss Pfizer’s application for authorization of a third… read more.

Moderna files CMA to EMA for mRNA 1273 booster dose in COVID-19

Written by | 8 Sep 2021

Moderna announced it has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19… read more.

Moderna announces submission of initial data to the FDA for mRNA-1273 at the 50 µg dose level

Written by | 7 Sep 2021

Moderna, Inc., announced it has initiated its submission to the FDA for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg… read more.

Pfizer and BioNTech announce submission of initial data to FDA to support booster dose of COVID-19 Vaccine

Written by | 31 Aug 2021

Pfizer Inc. and BioNTech SE announced that they have submitted Phase 1 data to the FDA to support the evaluation of a third, or booster, dose of the… read more.

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