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Myovant

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Sarepta rival NS Pharma files Duchenne drug with FDA

Another blow for Sarepta following FDA rejection earlier this year

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Lynparza scores another positive phase 3 prostate cancer study

In specific mutations, risk of death was reduced by 66%

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Acacia eyes February FDA verdict for refiled nausea drug Barhemsys

Back on track after being turned down twice

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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

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J&J puts pressure on rivals with new Erleada okay in prostate cancer

FDA previously granted priority review in this indication

- PMLiVE

Distribution of Novartis’ generic Zantac halted due to carcinogen concerns

Ranitidine medicines found to contain cancer-causing substance

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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

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BeiGene gets speedy US review for lymphoma drug zanubrutinib

First US filing is major milestone for Chinese firm

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