EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo

26 April 2019 - EMA has completed its assessment of the results of the ANNOUNCE study and concluded that Lartruvo ...

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Lilly to establish an access program for patients as it prepares to withdraw Lartruvo from the global market

25 April 2019 - Lilly is working to ensure current patients access to Lartruvo with limited interruption after it is ...

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Product withdrawn after overseas reports of inflammatory brain disorders

15 March 2018 - Consumers and health professionals are advised that Biogen Australia, in consultation with the TGA, will withdraw ...

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EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta

7 March 2018 - Evidence indicates risk of serious inflammatory brain disorders. ...

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Biogen and AbbVie announce the voluntary worldwide withdrawal of marketing authorisations for Zinbryta (daclizumab) for relapsing multiple sclerosis

2 March 2018 - Patient safety is the top priority for Biogen and AbbVie. ...

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Biocon pulls application for EU approval of two drugs

16 August 2017 - Biocon has withdrawn its application seeking European Union approval for two drugs after the EU drugs ...

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Endo gives in to FDA demand and agrees to yank its opioid painkiller

7 July 2017 - In the end, the executive team at Endo International blinked. ...

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Kamada announces withdrawal of European marketing authorisation application for inhaled alfa-1 anti-trypsin for treatment of alfa-1 anti-trypsin deficiency disease

22 June 2017 - Kamada today announced that the company has withdrawn the marketing authorisation application for its proprietary inhaled ...

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Sunesis Pharmaceuticals announces withdrawal of European marketing authorisation application for vosaroxin as a treatment for relapsed/refractory AML

1 May 2017 - Company’s primary development focus is non-covalent reversible BTK inhibitor SNS-062. ...

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EMA publishes withdrawal assessment report for Graspa

25 April 2017 - On 14 November 2016, Erytech Pharma officially notified the CHMP that it wishes to withdraw its application ...

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EMA publishes withdrawal assessment report for Zioxtenzo

25 April 2017 - On 18 January 2017, Sandoz officially notified the CHMP that it wishes to withdraw its application ...

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Cempra withdraws solithromycin marketing authorisation application in Europe

28 March 2017 - Company plans to resubmit application with additional data, in alignment with FDA strategy. ...

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Roche withdraws submission for Avastin

28 March 2017 - Roche was seeking a positive CADTH recommendation for the use of bevacizumab in combination with pemetrexed ...

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Array BioPharma provides update on FDA submission for binimetinib

20 March 2017 - NRAS mutant melanoma NDA withdrawn based on thorough discussions with FDA and following late cycle review meeting. ...

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AbbVie withdraws submission for Venclexta

10 January 2017 - Abbvie was seeking funding for venetoclax when used as a treatment for patients with chronic lymphocytic ...

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