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RSS FeedPosted 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 24 Jul 2025
Leriglitazone marketing authorisation application submitted for treatment of cerebral adrenoleukodystrophy has been validated by EMA
23 July 2025 - Minoryx Therapeutics and Neuraxpharm today announce that the marketing authorisation application for Minoryx’s lead candidate leriglitazone (Nezglyzal) ...
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 23 Jul 2025
European Commission approves Roche’s Itovebi for people with ER positive, HER2 negative, advanced breast cancer with a PIK3CA mutation
23 July 2025 - Approval based on INAVO120 data showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with ...
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 21 Jul 2025
EMA publishes agenda for 21-24 July 2025 CHMP meeting
21 July 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 21 Jul 2025
Bristol Myers Squibb’s supplemental new drug application for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis accepted for review across four regions globally
21 July 2025 - Bristol Myers Squibb today announced that the US FDA has accepted for review the supplemental new ...
Posted by Michael Wonder on 18 Jul 2025
European Commission grants conditional approval of Ezmekly
18 July 2025 - Ezmekly is the first and only therapy to receive marketing authorisation in the EU for both adults ...
Posted by Michael Wonder on 13 Jul 2025
Bayer files for EU approval of gadoquatrane
10 July 2025 - Submission of marketing authorization application to the EMA seeking approval for investigational low dose gadoquatrane for contrast-enhanced ...
Posted by Michael Wonder on 13 Jul 2025
European Commission approves Tevimbra in combination with chemotherapy as a first-line treatment for nasopharyngeal carcinoma
10 July 2025 - New indication based on results of RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival. ...
Posted by Michael Wonder on 09 Jul 2025
New Wegovy dose submitted to EMA for approval, with 1 in 3 trial participants achieving 25% or more weight loss
8 July 2025 - Novo Nordisk today announced the submission of an application to the EMA for approval of a new, ...
Posted by Michael Wonder on 05 Jul 2025
European Commission approves Biocon biologics’ denosumab biosimilars
3 July 2025 - Biocon Biologics today announced that the European Commission has granted marketing authorisation in the European Union ...
Posted by Michael Wonder on 04 Jul 2025
Vertex Announces European Commission approval of Alyftek, a new once daily CFTR modulator for the treatment of cystic fibrosis
1 July 2025 - Approximately 31,000 people with cystic fibrosis in the EU are now eligible for this new highly ...
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. ...