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- PMLiVE

Horizon Pharma

Biosimilars – the same, but different?

As more products reach European markets, US regulations are catching up with science

- PMLiVE

FDA follows WHO lead on biosimilar naming

Proposes adding suffixes to distinguish biosimilar drug names

- PMLiVE

FDA grants Tocagen’s glioblastoma drug orphan status

Puts the brain cancer gene therapy in-line for development incentives

- PMLiVE

FDA slams Kardashian West’s Instagram drug promotion

Morning-sickness drug firm Duchesnay criticised over social media marketing

- PMLiVE

FDA grants priority review for new Keytruda licence

Merck’s PD-1 drug being assessed for first-line melanoma patients

- PMLiVE

FDA approves world’s first 3D printed drug

Aprecia’s epilepsy treatment Spritam seen as the future of drug manufacturing

- PMLiVE

US medicine regulation reforms passed by House

The 21st Centrury Cures Act could make sweeping changes if ratified

Eli Lilly HQ

Lilly closes on US approval of lung cancer drug necitumumab

Indication for NSCLC looking likely after informal panel poll

- PMLiVE

Horizon launches $3bn hostile bid for Depomed

Horizon wants to add Depomed’s pain therapies and CNS drugs to its products

FDA teams up with PatientsLikeMe for patient data project

Will explore its potential to inform the regulator'approach to risk assessment

Gilead Sciences

Gilead files Complera follow-up with FDA

HIV therapy could be approved in the US by the end of this year

Teva Pharma logo

Teva set for FDA verdict on reslizumab early next year

Ruling for severe asthma therapy Cinquil expected by March 2016

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