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- PMLiVE

Keppra

- PMLiVE

Amgen says romosozumab on track for 2016 filing

Reports ‘significant’ reduction of fractures in post-menopausal osteoporosis patients

- PMLiVE

UCB bags FDA approval for epilepsy drug Briviact

Wins US licence as the add-on treatment is launched in Germany and the UK

- PMLiVE

Roche and AZ claim FDA breakthrough status for new drugs

Designation could speed up development for Roche’s ocrelizumab and AZ’s durvalumab 

- PMLiVE

Merck & Co’s oral hepatitis C therapy approved in US

Fixed-dose combination Zepatier wins a licence from the FDA

- PMLiVE

FDA verdict on Amgen’s Humira biosimilar due in September

Begins review the version of AbbVie's big-selling anti-inflammatory drug

Threat of medical device hacking is ‘growing concern’

FDA issues new cybersecurity guidance to help minimise risks

- PMLiVE

Pascale Richetta moves from AbbVie to UCB

She joins the biopharmaceutical company as executive vice president

- PMLiVE

UCB wins European approval for epilepsy drug Briviact

Plans first launches within weeks

- PMLiVE

Audit office says FDA ‘is not meeting safety data obligations’

Criticised for not effectively tracking information about approved drugs

EISAI

Eisai’s Lenvima gets FDA priority review for kidney cancer

The oncology treatment could now be approved in the US before the summer

- PMLiVE

FDA panel backs approval of first opioid addiction implant

Probuphine has been developed by Titan Pharma and partner Braeburn Pharma

- PMLiVE

Robert Califf moves a step closer to FDA leadership

US Senate committee backs his nomination to serve as the regulator's commissioner

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