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RSS FeedPosted 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 ...
Posted by Michael Wonder on 21 Sep 2023
BeiGene announces positive regulatory updates in Europe and the US after recently regaining global rights for Tevimbra
19 September 2023 - European Commission approves Tevimbra for previously treated advanced or metastatic oesophageal squamous cell carcinoma. ...
Posted by Michael Wonder on 21 Sep 2023
Biocon Biologics receives European Commission approval for Yesafili, biosimilar aflibercept
20 September 2023 - Biocon Biologics, a subsidiary of Biocon, has announced that the European Commission granted marketing authorisation in ...
Posted by Michael Wonder on 21 Sep 2023
European Commission approves Menarini Group’s Orserdu (elacestrant) for the treatment of patients with ER+, HER2- locally advanced or metastatic breast cancer with an activating ESR1 mutation
20 September 2023 - Orserdu is the first treatment specifically for patients with oestrogen receptor positive, HER2 negative advanced or metastatic breast ...
Posted by Michael Wonder on 21 Sep 2023
Takeda receives positive CHMP opinion for Adcetris (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30+ stage III Hodgkin lymphoma in combination with AVD
18 September 2023 - Takeda announced today that the CHMP of the EMA has adopted a positive opinion for the ...
Posted by Michael Wonder on 20 Sep 2023
CHMP adopts positive opinion to extend the use of Veklury (remdesivir) to treat COVID-19 in people with hepatic impairment
19 September 2023 - This positive opinion reinforces Veklury’s strong safety profile. ...
Posted by Michael Wonder on 20 Sep 2023
Tyenne, Fresenius Kabi’s tocilizumab biosimilar, receives European Commission approval
19 September 2023 - Tyenne is the first tocilizumab biosimilar approved by the European Commission. ...
Posted by Michael Wonder on 20 Sep 2023
Otsuka and Astex announce that the European Commission has approved Inaqovi (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute myeloid leukaemia
19 September 2023 - Otsuka and Astex Pharmaceuticals today announce that the European Commission has approved Inaqovi (oral decitabine and ...
Posted by Michael Wonder on 20 Sep 2023
European Commission approves Pfizer’s Litfulo for adolescents and adults with severe alopecia areata
19 September 2023 - Pfizer today announced that the European Commission has granted marketing authorisation for Litfulo (ritlecitinib) to treat adults ...