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- PMLiVE

Alkindi

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Finch Therapeutics bags $53m for microbiome therapies

In race to be first-to-market in C diff

- PMLiVE

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’

- PMLiVE

ICER closely monitoring FDA’s Zolgensma investigation

Could affect initial cost assessment

- PMLiVE

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

Bayer symbol

Bayer bags FDA nod for early prostate cancer drug darolutamide

new competition in the market

- PMLiVE

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

- PMLiVE

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

Will join Pfizer board

- PMLiVE

Resurgent Diurnal raises £5.4m for twin product filings

Company recovers after trial setback

- PMLiVE

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

Setback for AML candidate quizartinib

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