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RSS FeedPosted 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16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving ...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3 June 2022 - Bristol Myers Squibb today announced that the company has withdrawn a supplemental biologics license application for ...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15 April 2022 - TG Therapeutics today announced that the Company has voluntarily withdrawn the pending biologics license application/supplemental new drug ...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24 January 2022 - Swedish pharmaceutical company Oncopeptides announced that it has contacted the U.S FDA and rescinded its 22 ...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 08 Sep 2021
Withdrawals from pharmaceutical benefits on 1 October 2021
8 September 2021 - Suboxone is among the medicines that will be withdrawn from the drug benefits at the companies' ...
Posted by Michael Wonder on 06 Jul 2021
DoH publishes revised agenda for July 2021 PBAC meeting
6 July 2021 - Agenda revised on the eve of next scheduled meeting. ...
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) ...
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 ...