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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

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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

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FDA approves Myovant’s oral pill Orgovyx for prostate cancer

This is a new option for advanced prostate cancer patients in the US

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Moderna receives FDA emergency authorisation for its COVID-19 vaccine

Moderna's vaccine is the second to receive FDA approval, following approval of Pfizer/BioNTech’s BNT162b2 vaccine

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Amgen aims for first KRAS inhibitor approval in the US

Sotorasib is a potential treatment for advanced KRAS G12C-mutated NSCLC

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Moderna scores FDA panel backing for mRNA-based COVID-19 vaccine

EMA also brings forward review meeting of vaccine

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Novartis receives FDA breakthrough therapy designation for rare disease med

The Swiss pharma company is eyeing approval in PNH and C3G indications

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