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- PMLiVE

Gaucher disease

- PMLiVE

EMA in firing line as transparency debate widens

Swedish regulator claims EU agency withheld information on drug withdrawn from sale in 2008

- PMLiVE

GSK files combination skin cancer drug in US

Seeks FDA approval for Tafinlar - Mekinist combination in melanoma

AZ target Omthera files blood fat drug in US

FDA submission for Epanova in severe hypertriglyceridemia

- PMLiVE

Lilly/ Boehringer’s Lantus biosimilar accepted for EMA review

Moves pharma companies’ version of Sanofi's blockbuster insulin a step closer to approval

Croatia joins European medicines network

Follows country's membership of the European Union

- PMLiVE

Roche’s Perjeta on US fast-track for early breast cancer

FDA grants priority review for drug's use before surgery

- PMLiVE

FDA forces Achillion to delay hepatitis C programme

Abnormal liver functions detected in some patients taking sovaprevir

- PMLiVE

Setback for Merck & Co as FDA knocks back insomnia drug

US regulator asks for company to file for approval of a lower starting dose of suvorexant

- PMLiVE

US FDA nets $41m of illegal medicines in online pharmacy crackdown

Regulator shuts down 1,677 sites in global operation

- PMLiVE

EMA commits to disclosure of data from trials

Seeks feedback on clinical trial data access policy

- PMLiVE

US FDA approves Vibativ for lung infection caused by MRSA

Theravance’s drug backed to treat hospital-acquired bacterial pneumonia

Novartis building

US FDA deems Novartis’ heart failure candidate a ‘breakthrough’

Serelaxin demonstrates ability to reduce shortness of breath and lower chance of dying

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