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- PMLiVE

MNK-795

- PMLiVE

FDA wants more data on J&J’s arthritis drug Plivensia

Requests further evidence on the drug’s safety profile after patient deaths link

- 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

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

Ironwood claims FDA OK for former AZ gout drug

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

- 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

Living in fear

An evolutionary perspective reduces the risk  of missing something very important

AstraZeneca AZ

After MYSTIC setback, FDA gives some comfort to AZ

Awards its PD-L1 inhibitor Imfinzi breakthrough status in locally-advanced NSCLC

Eli Lilly HQ

Baricitinib delay casts a pall over Lilly’s results update

FDA requests further data that could keep the drug off the market for a couple of years

Bristol Myers Squibb logo

BMS wins first US immuno-oncology paediatric licence

FDA gives the green light to expanded use of its melanoma treatment Yervoy

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