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RSS FeedPosted by Michael Wonder on 27 Aug 2024
Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with paroxysmal nocturnal haemoglobinuria
27 August 2024 - Approval is based on COMMODORE 2, where subcutaneous PiaSky once a month was equivalent to intravenous eculizumab ...
Posted by Michael Wonder on 27 Aug 2024
Sifi receives European Commission approval for Akantior
26 August 2024 - Akantior (polihexanide) is the first and only approved drug for the treatment of acanthamoeba keratitis. ...
Posted by Michael Wonder on 26 Aug 2024
Merck receives European Commission approval for Winrevair (sotatercept) in combination with other pulmonary arterial hypertension therapies, for the treatment of pulmonary arterial hypertension in adult patients with functional class II-III
26 August 2024 - Winrevair is the first activin signaling inhibitor therapy for pulmonary arterial hypertension approved in Europe. ...
Posted by Michael Wonder on 26 Aug 2024
Ordspono (odronextamab) approved in the European Union for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
26 August 2024 - Approval of Ordspono is based on data demonstrating robust and durable responses in both relapsed/refractory follicular lymphoma ...
Posted by Michael Wonder on 26 Aug 2024
European Commission approves Balversa (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma
23 August 2024 - Approval based on THOR results, showing 36 percent reduction in risk of death with erdafitinib versus ...
Posted by Michael Wonder on 26 Aug 2024
European Commission approves Celltrion’s SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for the treatment of multiple chronic inflammatory diseases
25 August 2024 - The European Commission approval is based on the totality of evidence including the results from a Phase ...
Posted by Michael Wonder on 25 Aug 2024
Moderna receives European Commission approval for RSV vaccine mRESVIA
23 August 2024 - Moderna today announced that the European Commission has granted marketing authorisation for mResvia (mRNA-1345), an mRNA respiratory ...
Posted by Michael Wonder on 20 Aug 2024
European Commission grants second indication approval for Tepkinly (epcoritamab) for the treatment of adults with relapsed/refractory follicular lymphoma
20 August 2024 - AbbVie today announced that the European Commission has granted conditional marketing authorisation for Tepkinly (epcoritamab) as a ...
Posted by Michael Wonder on 14 Aug 2024
Lynparza and Imfinzi combination approved in the EU for patients with mismatch repair proficient advanced or recurrent endometrial cancer
14 August 2024 - First immunotherapy and PARP inhibitor combination approved in endometrial cancer. ...
Posted by Michael Wonder on 08 Aug 2024
Takeda receives European Commission approval for Adzynma (recombinant ADAMTS13) as the first and only recombinant ADAMTS13 replacement therapy for congenital thrombotic thrombocytopenic purpura
7 August 2024 - Approval based on totality of evidence, including results from the first randomised, controlled, open-label, cross-over Phase ...
Posted by Michael Wonder on 05 Aug 2024
UCB announces European Commission approval for 320 mg device presentations of Bimzelx (bimekizumab)
5 August 2024 - Patients requiring a 320 mg dose of bimekizumab will now have an alternative single injection option of ...
Posted by Michael Wonder on 01 Aug 2024
CHMP recommends Rybrevant (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR mutated non-small cell lung cancer after failure of prior therapy
31 July 2024 - CHMP recommends Rybrevant (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced ...
Posted by Michael Wonder on 01 Aug 2024
Prestige Biopharma's Herceptin biosimilar Tuznue receives positive CHMP opinion from the EMA
31 July 2024 - Following approval by the European Commission, Prestige Biopharma's Herceptin biosimilar Tuznue would become the first biosimilar from ...
Posted by Michael Wonder on 31 Jul 2024
EMA approves Bio-Thera Solutions' BAT1706 (Avzivi, bevacizumab), a biosimilar referencing Avastin
30 July 2024 - Bio-Thera Solutions today announced that the EMA has approved BAT1706 (bevacizumab), a biosimilar referencing Avastin. ...
Posted by Michael Wonder on 30 Jul 2024
European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion
30 July 2024 - Approval is based on data from two Phase 3 studies in branch and central retinal vein occlusion ...