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RSS FeedPosted by Michael Wonder on 25 May 2026
Henlius’ serplulimab receives positive CHMP opinion for the treatment of sqNSCLC
23 May 2026 - Henlius Biotech announced that serplulimab (Hetronifly), the company’s self-developed anti-PD-1 mAb, has received a positive opinion from ...
Posted by Michael Wonder on 22 May 2026
Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer
22 May 2026 - Recommendation based on SERENA-6 Phase 3 trial results which showed combination reduced the risk of disease progression ...
Posted by Michael Wonder on 22 May 2026
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive metastatic solid tumours
22 May 2026 - Based on three Phase 2 trials of AstraZeneca and Daiichi Sankyo’s Enhertu which showed clinically meaningful responses ...
Posted by Michael Wonder on 01 May 2026
OS Therapies announces EMA initiates rolling review of conditional marketing authorisation application for OST-HER2 in the prevention or delay of recurrence in fully resected pulmonary metastatic osteosarcoma
30 April 2026 - OS Therapies today announced that the EMA's Committee for Advanced Therapy, in conjunction with the CHMP and ...
Posted by Michael Wonder on 23 Apr 2026
Ojemda approved in the European Union as the first targeted therapy in relapsed or refractory pediatric low-grade glioma regardless of BRAF alteration
22 April 2026 - Approval is based on pivotal Phase 2 FIREFLY-1 data demonstrating meaningful and durable tumour responses. ...
Posted by Michael Wonder on 04 Apr 2026
European Commission approves Keytruda (pembrolizumab) plus paclitaxel ± bevacizumab for the treatment of adults with PD-L1 (CPS ≥1) platinum-resistant recurrent ovarian carcinoma who have received one or two prior systemic treatment regimens
2 April 2026 - Merck announced that Keytruda (pembrolizumab), in combination with paclitaxel, with or without bevacizumab, is approved in the ...
Posted by Michael Wonder on 01 Apr 2026
Henlius receives two positive CHMP opinions for serplulimab, advancing global regulatory progress
30 March 2026 - Shanghai Henlius Biotech today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly), ...
Posted by Michael Wonder on 28 Mar 2026
Johnson & Johnson’s Darzalex (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers
27 March 2026 - Johnson & Johnson today announced that the CHMP of the EMA has granted approval for a Type ...
Posted by Michael Wonder on 28 Mar 2026
Sanofi’s Sarclisa subcutaneous formulation administered via on body injector recommended for EU approval by the CHMP to treat multiple myeloma
27 March 2026 - Recommendation based on positive results demonstrating comparable efficacy, pharmacokinetics, and safety of Sarclisa regimens administered subcutaneously compared ...
Posted by Michael Wonder on 27 Mar 2026
Eisai and Nuvation Bio announce marketing authorisation application for taletrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer validated by the EMA
26 March 2026 - Additional filings are planned for the UK, Canada and other regions included in Eisai's licensed territories. ...
Posted by Michael Wonder on 20 Mar 2026
Bristol Myers Squibb transforms the classical Hodgkin lymphoma treatment paradigm with expanded US and EMA approvals for Opdivo (nivolumab)
20 March 2026 - Bristol Myers Squibb today announced that Opdivo (nivolumab) has received approval for two new classical Hodgkin ...
Posted by Michael Wonder on 16 Mar 2026
Imfinzi approved in the EU as first and only peri-operative immunotherapy for patients with early gastric and gastro-oesophageal cancers
16 March 2026 - Approval based on MATTERHORN Phase 3 trial demonstrating statistically significant and clinically meaningful improvements in event-free ...
Posted by Michael Wonder on 16 Mar 2026
EMA proposes new paper on proof of concept studies for paediatric oncology drugs
13 March 2026 - The EMA has released a concept paper proposing a future reflection paper on the development of ...
Posted by Michael Wonder on 11 Mar 2026
Tecvayli (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy
10 March 2026 - Johnson & Johnson today announced the submission of a type II variation application to the EMA seeking ...
Posted by Michael Wonder on 08 Mar 2026
Incyte announces the European Commission approval of Zynyz (retifanlimab) for the first-line treatment of advanced squamous cell carcinoma of the anal canal
6 March 2026 - The EC approval is based on results of the POD1UM-303 study which showed that adult patients with ...