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- PMLiVE

Celgene gets FDA OK for first oral psoriatic arthritis drug

Otezla wins US approval to treat the auto-immune disease

- PMLiVE

EMA backs Janssen rare disease drug for approval

Castleman's disease treatment Sylvant wins CHMP recommendation

- PMLiVE

Boehringer/Lilly’s empagliflozin among CHMP recommendations

If approved it will be marketed as Jardiance

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Bergstrom: Europe must collaborate on medicines value

EFPIA chief says national HTA bodies need to have shared process to assess value of new treatments

- PMLiVE

EMA looks at flexible drug licensing

Regulator looks to pilot programme to stagger approvals of new medicines

- 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

EMA to restrict use of domperidone and diacerein

Regulator's pharmacovigilance advisors also want insomnia drug zolpidem's labelling tightened up

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J&J gets EU green light for novel TB drug

Sirturo approved to treat multidrug resistant form of the disease

- 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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