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GSK immunotherapy

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UPDATED: Gilead says remdesivir likely to be effective against new COVID-19 strains

FDA approved the antiviral drug for the treatment of hospitalised COVID-19 patients in October 2020

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FDA priority review for Roche’s Esbriet in unclassifiable interstitial lung disease

Agency is due to make a decision for the approval by May 2021

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Janet Woodcock named acting commissioner of the FDA

President Biden is set to formally nominate a commissioner soon

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BMS aims for US approval of Opdivo combo in stomach cancer

US regulator has set a goal date for a decision on 25 May

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New dosing option for AZ’s Imfinzi approved in the EU and UK

Additional option extends dosing from two weeks to four weeks

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Bayer’s finerenone scores FDA priority review for chronic kidney disease

FDA priority review is based on data from the phase 3 FIDELIO-DKD trial

Roche Basel Switzerland

Roche’s flu pill Xofluza gains EU approval

EU approval is based on results from three phase 3 studies

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Two drugs found to reduce mortality in severe COVID-19 patients

Actemra and Kevzara also improved recovery times among critically ill COVID-19 patients

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Roche’s tiragolumab plus Tecentriq combo wins FDA breakthrough therapy designation

Swiss pharma is aiming for approval in first-line NSCLC

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FDA will not alter dosing schedules for authorised COVID-19 vaccines

Time period between first and second vaccines has been extended in the UK

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Inovio plans late-stage COVID-19 vaccine study in second quarter 2021

FDA had placed trial on a temporary hold in September 2020

Roche Basel Switzerland

Roche gets EU approval for fixed-dose Herceptin/Perjeta combination

Treatment can be administered as an injection instead of an intravenous infusion

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