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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 21 Aug 2024
EMA publishes agenda for 19-22 August 2024 CHMP meeting
19 August 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 19 Aug 2024
Bavarian Nordic submits data to EMA to extend Mpox/smallpox vaccine approval to adolescents
16 August 2024 - Interim results from clinical study show non-inferiority of immune responses from mpox/smallpox vaccination in adolescents and ...
Posted by Michael Wonder on 19 Aug 2024
EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
19 August 2024 - Application based on the TRANSCEND FL trial in which Breyanzi showed deep and durable responses and a ...
Posted by Michael Wonder on 19 Aug 2024
Enhertu type II variation application validated by EMA for patients with HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy
19 August 2024 - Submission based on DESTINY-Breast06 Phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated ...
Posted by Michael Wonder on 16 Aug 2024
EMA confirms acceptance of marketing application for AVT06, a proposed biosimilar to Eylea (aflibercept)
15 August 2024 - The approvals process is anticipated to be completed in the third quarter of 2025. ...
Posted by Michael Wonder on 16 Aug 2024
KalVista announces validation of marketing authorisation application by the EMA for sebetralstat for hereditary angioedema
15 August 2024 - KalVista Pharmaceuticals today announced that the EMA has validated the submission of a marketing authorisation application for ...
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. ...