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- PMLiVE

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- 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

Amgen’s roll-out of myeloma drug Kyprolis reaches UK

Company hopes to gain NICE approval later this year

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Sandoz files for approval of Neulasta biosimilar in Europe

Amgen facing increasing competition in global biosimilar market

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NICE backs Repatha but rejects cholesterol rival Praluent

New draft guidance marks a U-turn on Amgen's drug but knocks back Sanofi treatment

- 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

- PMLiVE

Mylan buys into six biosimilars, including Orencia candidate

Deal with Momenta bolsters biosimilars pipeline for new products

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