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- PMLiVE

Horizon Pharma

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EMA and FDA calls for innovative approaches for Gaucher disease medicines

The regulatory agencies also urge a similar method for all paediatric diseases

- PMLiVE

FDA moves to tackle orphan designation backlog

Some 200 requests are awaiting review by the US regulator

- PMLiVE

FDA panel backs CV claims for Novo Nordisk’s Victoza

LEADER trial shows the diabetes treatment reduces risk of cardiovascular death by 13%

Bayer symbol

Bayer wins FDA approval for MS electronic autoinjector and app

US regulator gives green light to Betaconnect and myBETA app

Eli Lilly HQ

FDA fast-tracks Pfizer and Lilly’s tanezumab

The novel pain drug treats osteoarthritis and chronic low back pain

- PMLiVE

Novo Nordisk’s long-acting haemophilia B drug cleared by FDA

US approval sets up marketing battle with Bioverativ and CSL Behring

Novartis building

Novartis’ Zykadia claims US approval for first-line lung cancer

The Swiss pharma giant’s drug also receives CHMP positive opinion

- PMLiVE

FDA panel backs Puma’s breast cancer drug, with reservations

Side effects concerns could see medicines limited

- PMLiVE

Keytruda is first FDA-approved drug for molecular indication

Indicates a significant development in the shift towards personalised medicine

Sanofi reception

Sanofi/Regeneron’s Sarilumab cleared by FDA on second attempt

IL-6 inhibitor to treat adult RA patients

- PMLiVE

Merck and Pfizer claim second FDA nod for cancer drug Bavencio

Analysts predict it will bring in sales of around $600m by 2020

- PMLiVE

Gottlieb heading to FDA after clearing Senate vote

Trump’s favoured candidate received bipartisan support despite criticism

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