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- PMLiVE

Monkeypox

- PMLiVE

FDA approves Bavarian Nordic’s smallpox and monkeypox vaccine

First live non-replicating vaccine for both diseases

Novartis building

Novartis points finger at AveXis execs in Zolgensma data scandal

Announces remediation plan including whistleblower scheme

- 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

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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