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RSS FeedPosted by Michael Wonder on 24 Dec 2024
Datopotamab deruxtecan application in the EU for patients with advanced non-squamous non-small sell lung cancer voluntarily withdrawn
24 December 2024 - Daiichi Sankyo and AstraZeneca have voluntarily withdrawn the marketing authorisation application in the EU for datopotamab ...
Posted by Michael Wonder on 14 Dec 2024
Alofisel withdrawn from the EU market
13 December 2024 - Benefit of treatment used in Crohn’s disease no longer demonstrated. ...
Posted by Michael Wonder on 08 Dec 2024
Autopsy of a drug withdrawal — the case of melphalan flufenamide
7 December 2024 - The accelerated approval pathway, which was established in 1992, has expedited approvals of drugs for serious and ...
Posted by Michael Wonder on 26 Sep 2024
Pfizer voluntarily withdraws all lots of sickle cell disease treatment Oxbryta (voxelotor) from worldwide markets
25 September 2024 - Pfizer announced today that it is voluntarily withdrawing all lots of Oxbryta (voxelotor) for the treatment of ...
Posted by Michael Wonder on 04 Apr 2024
Amylyx Pharmaceuticals announces formal intention to remove Relyvrio/Albrioza from the market
4 April 2024 - Based on top-line results from the Phase 3 PHOENIX trial of AMX0035 in ALS, Amylyx has started ...
Posted 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16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving ...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 06 Jun 2022
Bristol Myers Squibb withdraws supplemental biologics license application for Reblozyl (luspatercept-aamt) for non-transfusion dependent beta thalassaemia
3 June 2022 - Bristol Myers Squibb today announced that the company has withdrawn a supplemental biologics license application for ...
Posted by Michael Wonder on 15 Apr 2022
TG Therapeutics announces voluntary withdrawal of the BLA/sNDA for U2 to treat patients with CLL and SLL
15 April 2022 - TG Therapeutics today announced that the Company has voluntarily withdrawn the pending biologics license application/supplemental new drug ...
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 25 Jan 2022
Oncopeptides withdraws withdrawal of first marketed drug
24 January 2022 - Swedish pharmaceutical company Oncopeptides announced that it has contacted the U.S FDA and rescinded its 22 ...
Posted 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) ...