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RSS FeedPosted by Michael Wonder on 14 Feb 2023
Camurus withdraws variation application for CAM2038 to include chronic pain
13 February 2023 - Camurus announced today that it has notified the EMA of its decision to withdraw the Type ...
Posted by Michael Wonder on 16 Sep 2022
Prestige BioPharma voluntary withdraws EU license application for Herceptin biosimilar
16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving ...
Posted by Michael Wonder on 23 Mar 2022
Orphazyme announces withdrawal of European marketing authorisation application for arimoclomol for the treatment of Niemann-Pick disease type C
22 March 2022 - Decision to withdraw the European marketing authorisation application comes ahead of scheduled final vote on the ...
Posted by Michael Wonder on 19 Oct 2020
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. ...
Posted by Michael Wonder on 31 Jan 2020
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 ...
Posted by Michael Wonder on 27 Apr 2019
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 ...
Posted by Michael Wonder on 07 Mar 2018
EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta
7 March 2018 - Evidence indicates risk of serious inflammatory brain disorders. ...
Posted by Michael Wonder on 02 Mar 2018
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. ...
Posted by Michael Wonder on 20 Aug 2017
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16 August 2017 - Biocon has withdrawn its application seeking European Union approval for two drugs after the EU drugs ...
Posted by Michael Wonder on 23 Jun 2017
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 ...
Posted by Michael Wonder on 02 May 2017
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. ...
Posted by Michael Wonder on 26 Apr 2017
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 ...
Posted by Michael Wonder on 25 Apr 2017
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 ...
Posted by Michael Wonder on 29 Mar 2017
Cempra withdraws solithromycin marketing authorisation application in Europe
28 March 2017 - Company plans to resubmit application with additional data, in alignment with FDA strategy. ...
Posted by Michael Wonder on 21 Sep 2016
AstraZeneca withdraws cancer drug after 'differences of opinion' with regulator
21 September 2016 - AstraZeneca has suffered a setback after being forced to withdraw an application for a key ovarian cancer ...