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- PMLiVE

FDA fast-tracks Elan’s Alzheimer’s drug

Speeds up regulatory process for ELND005 for the treatment of neuropsychiatric symptoms

- PMLiVE

Setback for Teva as court dismisses Copaxone lawsuit

District Court dismisses claim that Mylan breached Teva’s patents on MS drug

- PMLiVE

FDA clears first brain test to diagnose ADHD in children

NEBA system available as part of wider clinical assessment

- PMLiVE

Boehringer breaks into oncology with FDA approval

Agency backs company's first cancer drug afatinib in lung cancer

- 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

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

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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