Blog
RSS FeedPosted 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 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
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 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 28 Jun 2025
Eylea 8 mg with extended 6 month treatment interval approved in the EU
27 June 2025 - The European Commission has granted a label extension in the EU for Eylea 8 mg (aflibercept 8 ...
Posted by Michael Wonder on 27 Jun 2025
Sephience (sepiapterin) granted marketing authorisation by the European Commission for the treatment of children and adults living with phenylketonuria
23 June 2025 - Launch to be initiated in Germany. ...
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
Ozempic receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and co-morbidities
23 June 2025 - Pending a decision from the European Commission, Ozempic (once weekly semaglutide) will have the broadest approved label ...
Posted by Michael Wonder on 24 Jun 2025
EMA recommends market approval of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept)
23 June 2025 - Alvotech and Advanz Pharma today announced that the EMA's CHMP adopted a positive opinion recommending approval for ...
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 21 Jun 2025
European Medicines Agency CHMP recommends EU approval of Partner Therapeutics Imreplys (sargramostim, rhu GM-CSF) to treat exposure to myelosuppressive doses of radiation (Haematopoietic Sub-syndrome of Acute Radiation Syndrome)
20 June 2025 - Partner Therapeutics today announced that the CHMP of the EMA has recommended approval of PTx's marketing authorisation ...
Posted by Michael Wonder on 20 Jun 2025
Zemcelpro (UM171 cell therapy) receives positive CHMP opinion for treatment of blood cancer patients without access to suitable donor cells
19 June 2025 - ExCellThera announced today the CHMP of the EMA has adopted a positive opinion, recommending granting conditional marketing ...
Posted by Michael Wonder on 17 Jun 2025
Averoa receives European marketing authorisation for Xoanacyl, an oral therapy for chronic kidney disease
16 June 2025 - AVEROA actively seeking strategic partners and investors to bring Xoanacyl to European patients and unlock full ...