Blog
RSS FeedPosted by Michael Wonder on 03 Jun 2025
MaaT Pharma submits marketing authorisation application to the EMA for Xervyteg (MaaT013) in acute graft versus host disease
2 June 2025 - The marketing authorisation application submitted to the EMA is based on data from the Pivotal ARES study, evaluating ...
Posted by Michael Wonder on 03 Jun 2025
Zealand Pharma submits marketing authorisation application to the EMA for glepaglutide in short bowel syndrome
2 June 2025 - Zealand Pharma today announced the submission of a marketing authorisation application to the EMA for glepaglutide, ...
Posted by Michael Wonder on 28 May 2025
Bristol Myers Squibb receives European Commission approval for the subcutaneous formulation of Opdivo (nivolumab) across multiple solid tumour indications
28 May 2025 - Approval is based on results from the Phase 3 CheckMate -67T clinical trial which demonstrated non-inferiority in ...
Posted by Michael Wonder on 27 May 2025
BeiGene receives positive CHMP opinion for Tevimbra as a first-line treatment for nasopharyngeal cancer
27 May 2025 - Positive opinion for Tevimbra in combination with chemotherapy as a first-line treatment of nasopharyngeal cancer based ...
Posted by Michael Wonder on 27 May 2025
Eylea 8 mg with extended 6 month treatment interval recommended for approval in EU
23 May 2025 - CHMP opinion is based on the findings from the pivotal clinical trials PULSAR in neovascular (wet) ...
Posted by Michael Wonder on 25 May 2025
Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in relapsed/refractory multiple myeloma
23 May 2025 - Positive opinion supported by superior efficacy shown in two head-to-head Phase 3 trials, including overall survival in ...
Posted by Michael Wonder on 25 May 2025
SpringWorks Therapeutics receives positive CHMP opinion for mirdametinib for the treatment of adult and paediatric patients with NF1-PN
23 May 2025 - If approved, mirdametinib is expected to be the first and only therapy in the European Union with ...
Posted by Michael Wonder on 23 May 2025
Soleno Therapeutics announces submission and EMA validation of marketing authorisation application for diazoxide choline prolonged release tablets for the treatment of hyperphagia in patients with Prader-Willi syndrome
22 May 2025 - Soleno Therapeutics today announced that Soleno’s marketing authorisation application seeking regulatory approval of diazoxide choline prolonged release ...
Posted by Michael Wonder on 16 May 2025
BMS receives European Commission approval for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by adjuvant Opdivo for resectable, high risk non-small cell lung cancer with PD-L1 expression ≥1%
16 May 2025 - Approval based on results from the CheckMate-77T trial which showed perioperative Opdivo improved event-free survival compared ...
Posted by Michael Wonder on 08 May 2025
European Commission approves Tremfya (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease
7 May 2025 - Data from the pooled GALAXI 2 and 3 studies showed that guselkumab demonstrated greater efficacy compared to ...
Posted by Michael Wonder on 06 May 2025
Calquence plus chemoimmunotherapy approved in the EU as first and only BTK inhibitor for first-line mantle cell lymphoma
6 May 2025 - Approval based on ECHO Phase III trial results which demonstrated over 16 months of progression-free survival ...
Posted by Michael Wonder on 29 Apr 2025
Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for first-line chronic lymphocytic leukaemia
29 April 2025 - Recommendation based on AMPLIFY Phase III trial which showed Calquence combinations demonstrated statistically significant and clinically ...
Posted by Michael Wonder on 28 Apr 2025
Lynozyfic (linvoseltamab) approved in the European Union for the treatment of relapsed/refractory multiple myeloma
28 April 2025 - Regeneron Pharmaceuticals today announced that the European Commission has granted conditional marketing approval of Lynozyfic (linvoseltamab) to ...
Posted by Michael Wonder on 28 Apr 2025
Vertex receives CHMP positive opinion for Alyftrek, a new once-daily CFTR modulator for the treatment of cystic fibrosis
28 April 2025 - In head-to-head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and superior compared to Kaftrio (ivacaftor/tezacaftor/elexacaftor) at ...
Posted by Michael Wonder on 28 Apr 2025
Jazz Pharmaceuticals receives CHMP positive opinion for zanidatamab for the treatment of advanced HER2 positive biliary tract cancer
25 April 2025 - Jazz Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending the ...