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- PMLiVE

Amgen’s Mvasi is first FDA-approved cancer biosimilar

Offers prospect of lower-cost alternative to Roche's Avastin

FDA approves first substance use mobile medical application

Pear Therapeutics' Reset device offers cognitive behavioural therapy

- PMLiVE

Bayer appoints Wolfgang Nickl as chief financial officer

He will succeed Johannes Dietsch on June 1, 2018

- PMLiVE

GSK’s Shingrix sails through FDA advisory committee

Shingles vaccine data proved safe and effective, says the panel

FDA poised to start digital health pilot

Forms a key part of the agency's new digital innovation action plan

- PMLiVE

NICE backs Allergan’s IBS therapy Truberzi

The £3 per day therapy was recommended in final guidance from the cost-effectiveness watchdog

- PMLiVE

Ironwood claims FDA OK for former AZ gout drug

Duzallo will be launched in the US before the end of this year

- PMLiVE

Bayer’s Nexavar backed by NICE for liver cancer

The drug is the only approved first-line treatment for advanced HCC

Bayer symbol

EMA clears Bayer’s Stivarga for liver cancer

The multikinase inhibitor will treat patients with HCC

- PMLiVE

Setback for J&J as FDA panel turns down arthritis drug sirukumab

US regulator concerned with the drug’s safety

AstraZeneca AZ

Clock starts ticking on FDA review of AZ’s acalabrutinib

If approved, the BTK inhibitor could achieve annual peak sales of $5bn

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