If approved, Vertex’s Casgevy (exagamglogene autotemcel) would be the first gene-editing medicine authorised in the European Union.
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Committee for Medicinal Products for Human Use (CHMP)
The European Commission has approved Europe's first treatment for adults with indolent systemic mastocytosis, a rare haematological disorder.
Newly appointed Vice President of Medical Affairs, Europe at BeiGene, Dr Jan-Henrik Terwey, provides exclusive insight on clinical development in the haematology/oncology space, and highlights significant data for its BCL-2 inhibitor, sonrotoclax.
If approved, momelotinib will be the first treatment in the EU indicated for myelofibrosis patients with moderate to severe anaemia.
Following the CHMP’s recommendation of a follicular lymphoma combination treatment, if approved, BRUKINSA will be the first BTK inhibitor to be authorised for follicular lymphoma.
Iveric Bio's marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat a leading cause of blindness has been accepted for review by the European Medicines Agency.
The European Commission (EC) has approved the first treatment for paediatric patients in the EU to treat seizures associated with CDKL5 deficiency disorder.
Extended EU approval of Soliris to paediatric generalised myasthenia gravis (gMG) patients is based on Phase III data which demonstrated improvement in disease severity through 26 weeks.
If approved by the European Commission (EC), ORSERDU® (elacestrant) would be the first treatment for ER+, HER2- advanced or metastatic breast cancer tumours with ESR1 mutations.
The first and only fully human biologic that directly inhibits interleukin-17A has been granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).