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- PMLiVE

Viaskin Peanut

- PMLiVE

Abeona Therapeutics’ rare disease phase 3 trial halted due to FDA concerns

Issues over transport stability must be resolved, says regulator

- 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

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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

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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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