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RSS FeedPosted by Michael Wonder on 02 Dec 2025
EMA validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for certain patients with muscle-invasive bladder cancer
1 December 2025 - Astellas Pharma today announced that the EMA validated for review a type II variation application for ...
Posted by Michael Wonder on 24 Nov 2025
Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory mantle cell lymphoma
24 November 2025 - In the TRANSCEND MCL trial, 82.7% of patients responded to Breyanzi, with 71.6% of patients achieving complete ...
Posted by Michael Wonder on 19 Nov 2025
Libtayo (cemiplimab) approved in the European Union as first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma with high risk of recurrence after surgery and radiation
19 November 2025 - Approval based on results of landmark Phase 3 C-POST trial that show Libtayo is first immunotherapy to ...
Posted by Michael Wonder on 19 Nov 2025
European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma
19 November 2025 - Roche announced today that the European Commission has granted conditional marketing authorisation of Lunsumio (mosunetuzumab) subcutaneous for ...
Posted by Michael Wonder on 17 Oct 2025
Libtayo (cemiplimab) recommended for EU approval by the CHMP for adjuvant treatment of cutaneous squamous cell carcinoma with a high risk of recurrence after surgery and radiation
17 October 2025 - Positive opinion based on results of Phase 3 C-POST trial that show Libtayo significantly reduced the ...
Posted by Michael Wonder on 17 Oct 2025
Novartis Scemblix receives positive CHMP opinion for the treatment of adults with newly diagnosed CML
17 October 2025 - If approved, Scemblix will be indicated for adults with chronic myeloid leukaemia (CML), both newly diagnosed and ...
Posted by Michael Wonder on 15 Oct 2025
Corcept submits marketing authorisation application to EMA for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
14 October 2025 - Corcept Therapeutics has submitted a marketing authorisation application to the EMA for relacorilant to treat patients ...
Posted by Michael Wonder on 23 Sep 2025
European Commission approves Servier's Voranigo (vorasidenib) as the first targeted therapy for grade 2 IDH mutant glioma in the EU
22 September 2025 - Voranigo demonstrated significant improvement in progression-free survival with a favourable safety profile in a pivotal Phase ...
Posted by Michael Wonder on 11 Sep 2025
Enhertu type II variation application validated in the EU for previously treated patients with HER2 positive metastatic solid tumours
11 September 2025 - Submission based on three Phase 2 trials where Daiichi Sankyo and AstraZeneca’s Enhertu showed clinically meaningful ...
Posted by Michael Wonder on 18 Aug 2025
European Commission grants approval of Ogsiveo
18 August 2025 - Merck KGaA announced today that the European Commission granted marketing authorisation for Ogisiveo (nirogacestat), an oral gamma ...
Posted by Michael Wonder on 29 Jul 2025
BeOne Medicines receives positive CHMP opinion for Tevimbra in neo-adjuvant/adjuvant NSCLC treatment
28 July 2025 - Recommendation based on Phase 3 RATIONALE-315 study, in which Tevimbra demonstrated clinically meaningful and statistically significant improvement ...
Posted by Michael Wonder on 26 Jul 2025
Sanofi’s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma
25 July 2025 - Approval based on GMMG-HD7 Phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD ...
Posted by Michael Wonder on 25 Jul 2025
Cabometyx approved in the EU for previously treated advanced neuroendocrine tumours
24 July 2025 - Approval based on pivotal CABINET Phase 3 trial which demonstrated a 77% and 62% reduction in ...
Posted by Michael Wonder on 25 Jul 2025
Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma
24 July 2025 - Two head-to-head Phase 3 trials demonstrated superior efficacy, including overall survival versus a daratumumab-based triplet in DREAMM-7. ...
Posted by Michael Wonder on 23 Jul 2025
European Commission approves Imbruvica (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant
23 July 2025 - Data from the Phase 3 TRIANGLE study defines the fixed-duration ibrutinib-based regimen as a new standard of ...