FDA seeks input on biomarker, endpoint glossary

24 July 2019 - Two-and-a-half years after its release, the US FDA is asking for input from the public on ...

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Pfizer calls for FDA guidance to address false and misleading biosimilar advertisements

28 August 2018 - Taking issue with Amgen, Genentech and other reference product sponsors’ dissemination of misleading information on biosimilars, ...

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First FDA approval agnostic of cancer site — when a biomarker defines the indication

11 October 2017 - In May 2017, the FDA approved pembrolizumab, a programmed death 1 inhibitor, for adult and paediatric patients ...

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Europe ready to embrace first copies of biotech cancer drugs

15 February 2017 - Treatment with two important cancer drugs is about to get much cheaper in Europe with a ...

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Biomarkers and surrogate endpoints

16 March 2016 - This Viewpoint describes the rationale behind an FDA and NIH effort to develop a glossary of common ...

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CADTH releases report on cancer biomarker testing

9 December 2015 - The final environmental ccan report is now available for the CADTH project on cancer biomarker testing. ...

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