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- PMLiVE

simvastatin

- PMLiVE

FDA explains draft Alzheimer’s guidance in NEJM editorial

Intends to relax requirements in patient function and cognition

- PMLiVE

Merck forges on with Vytorin trial after safety review

Won't halt controversial study of its cholesterol drug

FDA smartphone regulation could stifle innovation

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

- PMLiVE

Former Amgen R&D head Perlmutter to lead research at Merck & Co

Returns to US pharma firm after more than a decade away

- 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

- PMLiVE

Merck to develop biosimilars with Samsung-Biogen joint venture

Agreement with Samsung Bioepis covers several candidates

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

Merck settles Vytorin lawsuit for $688m

Had faced claims it held back negative data from clinical trials

- PMLiVE

Global counterfeit drug business driven by crime and corruption

Institute of Medicines says international cooperation needed to tackle falsified medicines

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