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- PMLiVE

icosapent ethyl

- PMLiVE

FDA’s year-end approvals take annual tally to 46

Rhopressa and Steglatro were among the final medicines licensed last year

- PMLiVE

Novo Nordisk gets FDA nod for once-weekly rival to Lilly’s Trulicity

GLP-1 agonist Ozempic approved in the US for type 2 diabetes

- PMLiVE

Mylan gets first biosimilar Herceptin OK from FDA

Ogivri approved by US regulators for all of Roche blockbuster's indications

- PMLiVE

FDA approves first Apple Watch medical device accessory

Kardia Band functions as a real-time electrocardiogram

AstraZeneca AZ

Setback for AZ as tralokinumab flunks asthma trial

Puts more pressure on AZ’s benralizumab to reach its potential

- PMLiVE

AZ gets early FDA green light for Imbruvica challenger

Sets up a marketing battle with Johnson/AbbVie

FDA approves new robotic surgery device

Senhance System backed for colorectal and gynaecological operations

Roche and J&J picked for ‘revolutionary’ digital health pilot

Firms will line up alongside Apple, Fitbit, Samsung and Verily in FDA pre-certification programme

Roche - Basel

Roche and J&J picked for ‘revolutionary’ digital health pilot

Firms will line up alongside Apple, Fitbit, Samsung and Verily in FDA pre-certification programme

- PMLiVE

J&J seeks US OK to add CV claim to Invokana label

If approved the treatment could better compete with rivals Jardiance and Victoza

UK flag

Universal flu vaccine heads for UK trials

New vaccine targets core proteins of the virus

- 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

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