EMA validates application for arpraziquantel to treat schistosomiasis in pre-school aged children

2 December 2022 - Merck, a leading science and technology company, and the Pediatric Praziquantel Consortium, today announced that the EMA ...

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European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...

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EQRx announces acceptance of marketing authorisation application by the European Medicines Agency for aumolertinib in EGFR mutated non-small-cell lung cancer

2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...

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European Commission grants expanded marketing authorisation for Gilead’s Biktarvy for the treatment of HIV in paediatric populations

29 November 2022 - European Commission authorises a low dose tablet for HIV treatment in virologically suppressed children at least two ...

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Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU

29 November 2022 -  Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...

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DARWIN EU welcomes first data partners

23 November 2022 - EMA has selected the first set of  data partners to collaborate with DARWIN EU, the Data Analysis ...

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AbbVie announces European Commission approval of Skyrizi (risankizumab) for the treatment of moderate to severe active Crohn's disease

23 November 2022 - Third approved indication for Skyrizi (risankizumab) and the first specific IL-23 inhibitor for the treatment of Crohn's ...

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Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy in second-line recurrent or metastatic cervical cancer irrespective of PD-L1 expression level or tumour histology

22 November 2022 - Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or ...

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New Quality Innovation Expert Group supports medicine innovation

21 November 2022 - The EMA has established a Quality Innovation Expert Group to support innovative approaches for the development, ...

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BeiGene receives European Commission approval for Brukinsa (zanubrutinib) for the treatment of adults with chronic lymphocytic leukaemia

17 November 2022 - Brukinsa is the only Bruton’s tyrosine kinase inhibitor to achieve superiority over ibrutinib in relapsed/refractory chronic lymphocytic ...

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European Commission approves Enjaymo (sutimlimab) for treatment of haemolytic anaemia in adult patients with cold agglutinin disease

17 November 2022 - Enjaymo is the first and only approved therapeutic option approved for haemolytic anaemia in adult patients ...

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Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as first-line treatment for patients with metastatic castration-resistant prostate cancer

14 November 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent in this ...

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Junshi Biosciences announces submission of a marketing authorisation application to the European Medicines Agency for toripalimab

14 November 2022 - The MAA was submitted in the EU for toripalimab seeking indications for the first-line treatment of NPC ...

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Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2 positive advanced gastric cancer

14 November 2022 - Based on DESTINY-Gastric02, which showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated clinically meaningful efficacy and DESTINY-Gastric01, which ...

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Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer

14 November 2022 - Positive opinion based on TOPAZ-1 Phase 3 trial updated survival results showing Imfinzi combination reduced risk ...

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