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- PMLiVE

Monkeypox

Novartis building

Novartis claims FDA breakthrough status for leukaemia treatment

Designation could speed up development and access for Novartis’ PKC412

- 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

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

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