Forxiga’s approval, based on unprecedented Phase III data, is the most significant advancement in chronic kidney disease (CKD) treatment in over 20 years.
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EMA's Committee for Medicinal Products for Human Use (CHMP)
Based on new clinical results, the EMA is recommending Moderna’s Spikevax COVID-19 vaccine be approved for use in children aged 12 to 17 years.
Drugs recommended for approval by the European Medicines Agency’s human medicines committee included a gene therapy and two generics, among five others.
The EMA is recommending that the Comirnaty® COVID-19 vaccine’s indication be extended to include children aged 12 to 15 years.
The European Commission has approved once daily oral Ponvory (ponesimod) for the treatment of relapsing multiple sclerosis in adult patients.
In its latest meeting the CHMP recommended eight medications for approval, 17 medicines for indication extension and concluded reviews of two COVID-19 treatments.
The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
In its March meeting the EMA’s human medicines committee recommended five medicines for approval and concluded its review of regdanvimab as a treatment for COVID-19.
The approval of at least one new manufacturing site based in Europe for each of the approved COVID-19 vaccines should increase supply for the EU.
In a high-risk patient cohort, treatment with the combination of bamlanivimab and etesevimab reduces COVID-19 related hospitalisation and death by 87 percent.
The human medicines committee decided that there was significant evidence to endorse the use of a combination of bamlanivimab and etesevimab in outpatients at high risk of severe COVID-19.
The EU regulator has begun reviewing preclinical and early trial data for Sputnik V, the COVID-19 vaccine developed by Russia.
The EMA’s committee adopted positive opinions of six medications, including two orphan drugs, and concluded its review of the use of REGN-COV2 – an investigational antibody therapy for COVID-19.