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RSS FeedPosted by Michael Wonder on 22 Feb 2021
Voluntary withdrawal of Imfinzi indication in advanced bladder cancer in the US
22 February 2021 - AstraZeneca today announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated ...
Posted by Michael Wonder on 28 Oct 2020
Leo Pharma is withdrawing the drug Picato (ingenol mebutate), used to treat skin lesions, due to the potential increased risk of skin cancer
27 October 2020 - At Health Canada's request, Leo Pharma is withdrawing Picato from the Canadian market. ...
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 05 Oct 2020
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) ...
Posted by Michael Wonder on 01 Oct 2020
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) ...
Posted by Michael Wonder on 14 Feb 2020
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. ...
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 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. ...