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- PMLiVE

Viaskin Peanut

- PMLiVE

Distribution of Novartis’ generic Zantac halted due to carcinogen concerns

Ranitidine medicines found to contain cancer-causing substance

- PMLiVE

Aimmune gets FDA panel backing for peanut allergy therapy

Step closer to becoming first approved treatment

- PMLiVE

Boehringer bags FDA OK for Ofev in rare lung disease ILD

First drug approved for condition

- PMLiVE

Novartis’ lung cancer drug wins FDA Breakthrough Therapy Designation

Provides hope for new treatment of rare cancer

- PMLiVE

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

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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

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