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- PMLiVE

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- PMLiVE

EMA to carry out four safety reviews

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

- PMLiVE

EU and Australian regulators collaborate on rare diseases

EMA and Therapeutic Goods Administration to share reports for orphan drugs

- PMLiVE

AbbVie drops legal case against EMA

Accepts publication of new set of redacted Humira data

- 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

- PMLiVE

Boehringer/Lilly’s empagliflozin among CHMP recommendations

If approved it will be marketed as Jardiance

- PMLiVE

EMA backs Janssen rare disease drug for approval

Castleman's disease treatment Sylvant wins CHMP recommendation

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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

EMA to restrict use of domperidone and diacerein

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

- PMLiVE

Gliptins don’t cause pancreatic cancer say FDA and EMA

Regulators back safety of diabetes medicine class

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Pharma wants review of EMA pharmacovigilance fees

EFPIA among associations to call for ‘balanced and transparent’ funding

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