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- PMLiVE

etelcalcetide

- 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

- PMLiVE

Celgene gets FDA OK for first oral psoriatic arthritis drug

Otezla wins US approval to treat the auto-immune disease

- PMLiVE

Amgen cholesterol antibody shines in rare disease trial

Evolocumab passes late-stage study

- PMLiVE

Pharma’s winners and losers in 2013

Roche, Johnson & Johnson and Amgen rise up the PMLiVE Top Pharma List rankings

- PMLiVE

FDA approves migraine headband

STX-Med’s electronic Cefaly device offers drug-free treatment option

- PMLiVE

FDA scrutiny of alirocumab hits Regeneron and Sanofi

Regulator to assess neurocognitive effects of cholesterol drug

- PMLiVE

Lilly/Boehringer’s empagliflozin faces US approval delay

FDA cites manufacturing issues with the new diabetes drug

- PMLiVE

Translational pharmacology: the key to ensuring safe and effective dosing

Designing pharmacokinetic and toxicokinetic studies during preclinical and early phase 1 trials will maximise a candidate’s chance of safety and efficacy success

- PMLiVE

GSK files Promacta for anaemia indication in US

FDA will review drug under ‘breakthrough’ designation

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