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cemiplimab

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Generics industry pressures FDA over biosimilar naming standards

GPhA says biosimilars should carry same name as branded biologic medicines

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NICE demands more data for Sanofi’s oral MS drug

UK body won't recommend Aubagio for NHS use based on current information

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This month in 2010: How one woman helped prevent a health crisis in the US

The FDA's Frances Oldham Kelsey honoured for her work to prevent the use of thalidomide

Sanofi reception

Sanofi wins EU approval for second MS drug in a month

EC approves Lemtrada weeks after Aubagio gets greenlight

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Breakthrough status for GSK/ Genmab’s Arzerra

Speeds up FDA review for use in chronic lymphocytic leukaemia

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Sanofi pulls Lyxumia’s US filing

Says will resubmit diabetes drug for FDA approval in 2015

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FDA panel backs Perjeta in early breast cancer

Unanimous recommendation for use alongside Herceptin

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FDA guidance clears path for Advair generics

Offers simplified process for potential copies of GSK’s asthma and COPD drug

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Celgene wins US pancreatic cancer indication for Abraxane

Adds to breast cancer and lung cancer indications

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FDA grants priority review to Takeda’s colitis drug

Accelerates review time for vedolizumab

National Institute for Health and Care Excellence NICE logo

NICE questions cost of medicines development

Says pharma should determine if R&D spending of £1bn+ per drug is really necessary

- PMLiVE

Sanofi plans its mobile diabetes future

Next phase of iBGStar project will focus on wider connectivity

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