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- PMLiVE

Gilead claims FDA okay for Descovy as second PrEP option

Can now push new indication before generics dent franchise

- PMLiVE

Sarepta rival NS Pharma files Duchenne drug with FDA

Another blow for Sarepta following FDA rejection earlier this year

It’s the guns, stupid

Gun violence in the US – a public health issue – can be better understood through three points

- PMLiVE

Acacia eyes February FDA verdict for refiled nausea drug Barhemsys

Back on track after being turned down twice

- 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

Envision Pharma Group relocates to support expansion

Office moves in the US prompted by significant growth

- 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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