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BeiGene gets speedy US review for lymphoma drug zanubrutinib

First US filing is major milestone for Chinese firm

Novartis day

Senators attack Novartis over ‘unconscionable’ handling of Zolgensma data

Ask FDA to hold the company ‘accountable’

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ICER closely monitoring FDA’s Zolgensma investigation

Could affect initial cost assessment

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DBV refiles peanut allergy immunotherapy in the US

Follows initial manufacturing concerns

Novartis day

Novartis defends Zolgensma as FDA investigates ‘data manipulation’

Gene therapy will remain on the market

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Bayer bags FDA nod for early prostate cancer drug darolutamide

new competition in the market

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FDA will maintain the pace, vows Woodcock, but warns of skills gap

Top official unconcerned by dip in approval rate

Battling breast cancer with precision medicine (Part 2)

Dr Mark Moasser treated breast cancer survivor Laura Holmes-Haddad (interviewed in part one) with an innovative precision medicine, which at the time was yet to be approved. Here he gives...

Blue Latitude Health

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Ex-FDA chief Gottlieb’s quick move to pharma raises eyebrows

Will join Pfizer board

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McCann’s Breath of Life diagnostic wins Cannes Lion prize

Grand Prix awarded for first time in three years

Novartis day

Novartis close to US bribery settlement

Company faces huge damages pay out

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One hit, one miss as FDA panel votes on Daiichi’s cancer drugs

Setback for AML candidate quizartinib

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