Blog
RSS FeedPosted by Michael Wonder on 08 Nov 2024
Johnson & Johnson submits applications in the US and EU seeking approval of Darzalex Faspro/Darzalex as subcutaneous monotherapy for high risk smoldering multiple myeloma
8 November 2024 - If approved, Darzalex Faspro will become the first treatment option for patients with smoldering multiple myeloma at ...
Posted by Michael Wonder on 24 Oct 2024
Merck’s Keytruda (pembrolizumab) receives 30th approval from European Commission with two new indications in gynaecologic cancers
24 October 2024 - Keytruda plus chemotherapy is the first approval in the EU for an anti-PD-1 therapy combined with chemotherapy ...
Posted by Michael Wonder on 18 Oct 2024
Novartis receives positive CHMP opinion for Kisqali to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
18 October 2024 - Recommendation is based on the Phase 3 NATALEE trial, where Kisqali added to endocrine therapy significantly reduced ...
Posted by Michael Wonder on 15 Oct 2024
Bayer submits application for third indication of darolutamide in the EU
14 October 2024 - Submission is based on positive results from the pivotal Phase 3 ARANOTE trial, which showed that darolutamide ...
Posted by Michael Wonder on 11 Oct 2024
Johnson & Johnson submits application to the EMA for Darzalex (daratumumab) SC based quadruplet regimen for newly diagnosed multiple myeloma patients
10 October 2024 - Submission supported by data from the Phase 3 CEPHEUS study for the treatment of patients with newly ...
Posted by Michael Wonder on 24 Sep 2024
Merck receives positive EU CHMP opinions for Keytruda (pembrolizumab) regimens as treatment for patients with two types of gynaecologic cancers
20 September 2024 - Positive opinion granted for Keytruda plus chemotherapy for the first-line treatment of adult patients with primary advanced ...
Posted by Michael Wonder on 23 Sep 2024
Henlius and Intas receive positive CHMP opinion for Hetronifly in European markets as first-line treatment for adult patients with extensive-stage small cell lung cancer
21 September 2024 - Hetronifly (serplulimab) is expected to become the first anti-PD-1 monoclonal antibody available in Europe for first-line treatment ...
Posted by Michael Wonder on 21 Sep 2024
Astellas receives approval from the European Commission for Vyloy (zolbetuximab) in combination with chemotherapy for advanced gastric and gastro-oesophageal junction cancer
20 September 2024 - Treatment with the claudin 18.2 targeted monoclonal antibody shown to significantly extend both progression-free survival and ...
Posted by Michael Wonder on 20 Sep 2024
AbbVie receives positive CHMP opinion for mirvetuximab soravtansine (Elahere) for the treatment of certain adult ovarian cancer
20 September 2024 - AbbVie today announced that the EMA's CHMP has adopted a positive opinion recommending the marketing authorisation of ...
Posted by Michael Wonder on 11 Sep 2024
Pierre Fabre Laboratories receives European Commission approval for Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation
30 August 2024 - European approval is based on results from the Phase 2 PHAROS trial, which showed a meaningful ...
Posted by Michael Wonder on 29 Aug 2024
European Commission approves 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
27 August 2024 - Amivantamab in combination with chemotherapy is the first treatment regimen to show significant improvement in progression-free survival ...
Posted by Michael Wonder on 28 Aug 2024
European Commission approves Astellas' Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for first-line treatment of advanced urothelial cancer
28 August 2024 - European marketing authorisation based on positive overall survival and progression-free survival results from the global Phase ...
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 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 ...