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Novartis building

Novartis gets US nod for lung cancer relapse therapy Zykadia

Second ALK inhibitor to be approved after Pfizer’s Xalkori

- PMLiVE

Following the biologic path

Biosimilar regulations in Canada, the US and Europe all have a degree of uncertainty

- PMLiVE

FDA approves Janssen drug for rare Castleman’s disease

Sylvant approved to treat lymphoma-like condition

- PMLiVE

Lilly’s stomach cancer drug cleared by FDA

Cyramza is tipped to reach blockbuster status depending on approvals

- PMLiVE

GSK gets OK in US for diabetes drug albiglutide

Once-weekly Tanzeum will compete against Victoza and Byetta after FDA approval

- PMLiVE

Boehringer’s Pradaxa wins FDA backing for DVT

 Anticoagulant sees uses expanded in the US

- PMLiVE

FDA backs heroin overdose treatment

Evzio comes in auto injector to be used by family members or carers

- PMLiVE

MannKind’s inhaled insulin backed for US approval

Afrezza finally on course for FDA approval in diabetes after two rejections

- PMLiVE

Doctors criticise FDA over Lemtrada rejection

Say Sanofi/Genzyme’s MS drug should have been approved

Novartis building

FDA panel rejects Novartis’ heart failure hope serelaxin

Decision follows EMA knock back earlier this year

Novartis building

More bad news for Novartis on heart failure candidate

FDA reviewers recommend against approving serelaxin

- PMLiVE

Pfizer’s meningitis vaccine ‘a breakthrough’

FDA to speed up review process for bivalent rLP2086

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