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- PMLiVE

cemiplimab

- PMLiVE

FDA explains draft Alzheimer’s guidance in NEJM editorial

Intends to relax requirements in patient function and cognition

FDA smartphone regulation could stifle innovation

US House Republicans issue warning on guidance and call for more information

- PMLiVE

Novo’s Lantus rival Tresiba hits European markets

Company says its insulin degludec is a more flexible alternative to Sanofi's product

- PMLiVE

Sanofi gets EMA backing for multi-disease vaccine in children

Hexyon-Hexacima 6-in-1 paediatric vaccine recommended for approval in Europe

- PMLiVE

Second approval in US for Bayer-Onyx’ Stivarga

FDA clears drug to treat patients with gastrointestinal stromal tumours

Roche - Basel

Roche’s Herceptin follow-up cleared in US

FDA approval for Kadcyla (formerly T-DM1) in breast cancer

Search appears on FDA’s radar once again

Warning letter to Florida company puts new slant on regulator's digital focus

- PMLiVE

GSK’s COPD drug Anoro under review in US

FDA accepts new drug application for the LAMA/LABA combination

Sanofi reception

FDA to review Sanofi’s lixisenatide for diabetes

Follows drug's European approval under brand name Lyxumia earlier this month

- PMLiVE

Genzyme on track for eliglustat filing in 2013

Says oral Gaucher disease drug as effective as its injectable Cerezyme

- PMLiVE

Global counterfeit drug business driven by crime and corruption

Institute of Medicines says international cooperation needed to tackle falsified medicines

- PMLiVE

Pharma bites back against Obama’s healthcare proposals

Call to cut Medicare payments for prescription drugs

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