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- PMLiVE

icosapent ethyl

- 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

- PMLiVE

FDA expands efforts to test quality of generics

Monitoring programme to ensure drug copies are equivalent to branded medicines

- PMLiVE

EMA and FDA create pharmacovigilance ‘cluster’

Monthly meetings to discuss key issues in medicines safety

- PMLiVE

FDA mulls use of side effect voiceover in TV advertising

Agency considers updating how drug risks are communicated

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