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RSS FeedPosted by Michael Wonder on 29 May 2025
Pfizer and BioNTech submit EMA application for COVID-19 vaccine targeting LP.8.1 for 2025-2026 season
28 May 2025 - 2025 -- Pfizer and BioNTech today announced that they have submitted a regulatory application to the ...
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
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 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 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 ...
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 22 May 2025
PharmaMar has submitted EU marketing authorization application for lurbinectedin in combination with atezolizumab in first-line maintenance therapy for extensive-stage small cell lung cancer
21 May 2025 - PharmaMar has submitted a marketing authorisation application to the EMA for Zepzelca (lurbinectedin) in combination with ...
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 14 May 2025
EMA starts review of Ixchiq (live attenuated chikungunya vaccine)
7 May 2025 - The vaccine must not be used in people 65 years and above while review is underway. ...
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 ...