Agios announces withdrawal of European marketing authorisation application for Tibsovo as a treatment for relapsed or refractory IDH1 mutant acute myeloid leukaemia

16 October 2020 - Agios continues to advance two Phase 3 combination trials of Tibsovo in newly diagnosed AML patients. ...

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CDER proposes withdrawal of approval for Makena

5 October 2020 - Today, the U.S. FDA’s Center for Drug Evaluation and Research proposed that Makena (hydroxyprogesterone caproate injection) ...

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Fibristal (ulipristal acetate 5 mg tablets) voluntary withdrawal in Canada due to risk of drug-induced liver injury

30 September 2020 - Allergan is working closely with Health Canada to voluntarily withdraw Fibristal (ulipristal acetate 5 mg tablets) ...

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FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market

13 February 2020 - Potential risk of cancer outweighs the benefits. ...

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Bristol-Myers Squibb withdraws European application of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of advanced non-small cell lung cancer

31 January 2020 - Company committed to first-line lung cancer patients in Europe, U.S. and other markets with planned filing of ...

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Nektar issues statement regarding FDA Advisory Committee vote for oxycodegol

15 January 2020 - Nektar Therapeutics issued a statement today following a meeting of the FDA's Anesthetic and Analgesic Drug ...

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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Product withdrawn after overseas reports of inflammatory brain disorders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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