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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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, ...

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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 ...

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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 ...

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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 ...

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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. ...

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Johnson & Johnson submits application to the EMA seeking indication extension of Akeega (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations

3 July 2025 - The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with ...

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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 ...

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Omeros submits narsoplimab marketing authorization application to the EMA for the treatment of TA-TMA

27 June 2025 - Omeros Corporation today announced the recent submission of a marketing authorisation application to the EMA for ...

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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. ...

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Philogen provides update on marketing authorisation application for Nidlegy in the European Union

24 June 2025 - Philogen today announced the decision to voluntarily withdraw the application for marketing authorisation to the EMA ...

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