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16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving ...

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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3 June 2022 - Bristol Myers Squibb today announced that the company has withdrawn a supplemental biologics license application for ...

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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15 April 2022 - TG Therapeutics today announced that the Company has voluntarily withdrawn the pending biologics license application/supplemental new drug ...

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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 ...

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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24 January 2022 - Swedish pharmaceutical company Oncopeptides announced that it has contacted the U.S FDA and rescinded its 22 ...

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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8 September 2021 - Suboxone is among the medicines that will be withdrawn from the drug benefits at the companies' ...

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DoH publishes revised agenda for July 2021 PBAC meeting

6 July 2021 - Agenda revised on the eve of next scheduled meeting. ...

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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 ...

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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.  ...

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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. ...

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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) ...

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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) ...

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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. ...

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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 ...

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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 ...

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