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RSS FeedPosted by Michael Wonder on 16 Jan 2020
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 ...
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 25 Apr 2019
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 ...
Posted by Michael Wonder on 15 Mar 2018
Product withdrawn after overseas reports of inflammatory brain disorders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 ...
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16 August 2017 - Biocon has withdrawn its application seeking European Union approval for two drugs after the EU drugs ...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 08 Jul 2017
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. ...
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22 June 2017 - Kamada today announced that the company has withdrawn the marketing authorisation application for its proprietary inhaled ...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 28 Mar 2017
Roche withdraws submission for Avastin
28 March 2017 - Roche was seeking a positive CADTH recommendation for the use of bevacizumab in combination with pemetrexed ...
Posted by Michael Wonder on 20 Mar 2017
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. ...