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- PMLiVE

ICMRA

- PMLiVE

EMA to carry out four safety reviews

And recommends against combination of medicines affecting RAS system in latest PRAC highlights

- PMLiVE

Boehringer’s Pradaxa wins FDA backing for DVT

 Anticoagulant sees uses expanded in the US

- PMLiVE

EU and Australian regulators collaborate on rare diseases

EMA and Therapeutic Goods Administration to share reports for orphan drugs

- PMLiVE

FDA backs heroin overdose treatment

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

- PMLiVE

AbbVie drops legal case against EMA

Accepts publication of new set of redacted Humira data

- 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

- PMLiVE

EMA’s Dr Stella Blackburn joins Quintiles

Takes up global head of risk management post

- PMLiVE

GSK withdraws melanoma combo in EU

EMA says it needs more data to review Mekinist and Tafinlar

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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