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RSS FeedPosted by Michael Wonder on 19 Oct 2023
European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30 positive stage III Hodgkin lymphoma in combination with AVD
18 October 2023 - Approval based on updated positive overall survival results from the Phase 3 ECHELON-1 study for stage III ...
Posted by Michael Wonder on 18 Oct 2023
Merck receives positive EU CHMP opinion for Prevymis for prevention of CMV disease in high risk adult kidney transplant recipients and extended 200 day dosing in adult HSCT recipients at risk for late CMV infection and disease
17 October 2023 - Merck today announced that the CHMP of the EMA has recommended the approval of Prevymis (letermovir) for ...
Posted by Michael Wonder on 17 Oct 2023
GSK receives positive CHMP opinion recommending approval of Jemperli (dostarlimab) plus chemotherapy as a new frontline treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer
16 October 2023 - If approved, dostarlimab would become the first new frontline treatment option in the European Union in ...
Posted by Michael Wonder on 16 Oct 2023
Mundipharma and Cidara Therapeutics receive positive CHMP opinion for rezafungin for the treatment of invasive candidiasis in adults
13 October 2023 - The opinion was based on positive results from the pivotal ReSTORE Phase 3 clinical trial and supported ...
Posted by Michael Wonder on 16 Oct 2023
Santhera receives positive CHMP opinion recommending approval of Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy
13 October 2023 - Agamree could become the first drug fully approved by the EMA for the treatment of patients with Duchenne ...
Posted by Michael Wonder on 16 Oct 2023
EU delays approval of Novavax's revised COVID vaccine
16 October 2023 - European Union regulators have delayed a decision to give approval for Novavax's variant-tailored COVID-19 vaccine, the ...
Posted by Michael Wonder on 14 Oct 2023
Amylyx Pharmaceuticals receives negative CHMP opinion on its marketing authorisation application for AMX0035 for the treatment of ALS in the European Union following re-examination process
13 October 2023 - Final decision from the European Commission expected by the end of 2023. ...
Posted by Michael Wonder on 13 Oct 2023
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) in relapsed or refractory follicular lymphoma
13 October 2023 - If approved, Brukinsa will be the first and only BTK inhibitor approved for follicular lymphoma. ...
Posted by Michael Wonder on 13 Oct 2023
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for HER2 negative advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
13 October 2023 - Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE-859 trial. ...
Posted by Michael Wonder on 13 Oct 2023
Astellas receives positive CHMP opinion for Veoza (fezolinetant)
13 October 2023 - Fezolinetant is an investigational non-hormonal treatment for vasomotor symptoms associated with menopause. ...
Posted by Michael Wonder on 13 Oct 2023
Vueway (gadopiclenol) receives positive CHMP opinion
12 October 2023 - The CHMP of the EMA recommended approval of the macrocyclic, high relaxivity Vueway (gadopiclenol) in adults ...
Posted by Michael Wonder on 26 Sep 2023
Sandoz receives European Commission approval for Tyruko (natalizumab), first and only biosimilar for multiple sclerosis in Europe
26 September 2023 - Decision based on evidence from extensive analytical characterisation demonstrating similarity of biosimilar with reference biologic, in addition ...
Posted by Michael Wonder on 25 Sep 2023
AbbVie announces European Commission approval of Tepkinly (epcoritamab) for adults with relapsed or refractory diffuse large B-cell lymphoma
25 September 2023 - Conditional marketing authorisation approval from the European Commission is supported by data from the pivotal Phase 1/2 ...
Posted by Michael Wonder on 23 Sep 2023
Jazz Pharmaceuticals receives European Commission approval for Enrylaze (a recombinant Erwinia asparaginase or crisantaspase) for the treatment of acute lymphoblastic leukaemia and lymphoblastic lymphoma
21 September 2023 - Jazz Pharmaceuticals today announced that the European Commission has granted marketing authorisation for Enrylaze (JZP458; a recombinant ...
Posted by Michael Wonder on 23 Sep 2023
European Commission authorises ViiV Healthcare’s Apretude (cabotegravir long-acting and tablets) for HIV prevention
19 September 2023 - Given as few as six times per year, cabotegravir has demonstrated superior efficacy to a daily oral ...