Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 22 Jul 2025
Bayer’s Nubeqa (darolutamide) receives EU approval in third indication for patients with advanced prostate cancer
21 July 2025 - Approval is based on positive results from the pivotal Phase 3 ARANOTE trial and reinforces darolutamide’s established ...
Posted by Michael Wonder on 04 Jul 2025
Imfinzi approved in the EU as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
4 July 2025 - Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk ...
Posted by Michael Wonder on 04 Jul 2025
Jazz Pharmaceuticals receives European Commission marketing authorisation for Ziihera (zanidatamab) for the treatment of advanced HER2 positive biliary tract cancer
1 July 2025 - Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial. ...
Posted by Michael Wonder on 04 Jul 2025
Johnson & Johnson submits application to the EMA seeking indication extension of Akeega (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations
3 July 2025 - The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with ...
Posted by Michael Wonder on 26 Jun 2025
BeOne Medicines receives positive CHMP opinion for tablet formulation of Brukinsa
25 June 2025 - BeOne Medicines today announced that the CHMP of the EMA issued a positive opinion recommending approval ...
Posted by Michael Wonder on 24 Jun 2025
Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma
23 June 2025 - Recommendation based on GMMG-HD7 Phase 3 study demonstrating that Sarclisa with bortezomib, lenalidomide, and dexamethasone induction treatment significantly ...
Posted by Michael Wonder on 06 Jun 2025
Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the first-line setting
6 June 2025 - AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for ...
Posted by Michael Wonder on 03 Jun 2025
European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with newly diagnosed stage IIb/III/IV Hodgkin lymphoma in combination with ECADD
3 June 2025 - Approval based on positive results from the Phase 3 HD21 trial for stage IIb with risk factors/III/IV ...
Posted by Michael Wonder on 27 May 2025
Imfinzi recommended for approval in the EU by CHMP as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
27 May 2025 - Recommendation based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 25 May 2025
CHMP recommends EU approval of Roche’s Itovebi for PIK3CA mutated, ER positive, HER2 negative, advanced breast cancer
23 May 2025 - Positive recommendation based on Phase 3 INAVO120 data showing Itovebi (inavolisib) in combination with palbociclib and fulvestrant ...