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- PMLiVE

Alkindi

- 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

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

Roche Basel Switzerland

Roche prepares to file atezolizumab for bladder cancer

Imminent submission to the FDA after additional positive phase II trial results

Gilead Sciences

Priority FDA review for new Gilead HCV combination therapy

Sovaldi/velpatasvir combination could be approved in the US by summer 2016

- PMLiVE

FDA approvals hit 19-year high

US regulator cleared 45 NMEs in 2015, its highest tally since 1996

- PMLiVE

Nucala price far too high for US market, says ICER

Concludes GlaxoSmithKline's new severe asthma therapy is not value for money

- PMLiVE

Merck finally bags FDA approval for Bridion

Follows three unsuccessful attempts to gain a US licence for the drug

- PMLiVE

FDA panel rejects cardiovascular outcomes claim for Vytorin

Merck & Co fail to convince regulator's advisors

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