A patient-centric legal framework intends to return clinical trial data to study participants, ready for re-use in further research or healthcare practice.
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European Commission (EC)
The European Commission has approved Libtayo® for cervical cancer and disease progression while on or after platinum-based chemotherapy, due to positive Phase III trial results.
The EC has authorised the first UL97 protein kinase inhibitor for adults with post-transplant refractory cytomegalovirus infection.
The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
Opdivo® (nivolumab) has been approved by the European Commission for gastric, gastroesophageal junction (GEJ), or oesophageal adenocarcinoma.
In its most recent meeting, the CHMP recommended nine new medicines and concluded its review of Vaxzevria’s thrombosis risk.
Kisqali plus letrozole achieved a median overall survival of over five years, the longest ever reported for HR+/HER2 breast cancer.
Johnson & Johnson’s Ebola vaccine regimen, Zabdeno® and Mvabea®, generated robust humoral immune responses in adults and children.
Bimzelx® (bimekizumab) becomes the first medicine to be evaluated and recommended through NICE’s new Expedited Low-Risk Fast Track Appraisal.
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
BioNTech will evaluate mRNA vaccine manufacturing facilities in Rwanda and Senegal to support vaccine supply in African states.
European Commission (EC) approves Minjuvi with lenalidomide for the treatment of large B-cell lymphoma in adults.