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- PMLiVE

Keppra

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

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

- PMLiVE

Gliptins don’t cause pancreatic cancer say FDA and EMA

Regulators back safety of diabetes medicine class

- PMLiVE

AZ gets limited approval for metreleptin in US

First FDA-backed treatment for rare disease lipodystrophy

Bristol-Myers Squibb (BMS) building

BMS’ oral hepatitis C regimen gets breakthrough status

Combines daclatasvir and asunepravir

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