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Enhertu approved in EU for HER2-low breast cancer
The European Commission has approved Enhertu in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
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European Commission (EC)
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EU antibiotic shortages being monitored by MSSG
The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) have stated it is closely monitoring and responding to the current EU antibiotic shortages.
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Pre-filled asthma pen approved for self-administration in EU
Tezspire is the first biologic approved in Europe for severe asthma with no phenotype or biomarker limitation, says AstraZeneca EVP.
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EC approves influenza antiviral for children over one years old
Xofluza® offers the first novel mechanism of action for an influenza antiviral to be approved by the European Commission in almost 20 years.
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Lynparza combination approved in EU for advanced prostate cancer
Patients in the EU with an advanced prostate cancer will benefit from a newly approved Lynparza-based treatment combination for the first time.
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World’s first approval of an allogeneic T-cell immunotherapy
Ebvallo™ is the first authorised allogeneic T-cell immunotherapy and has been approved for EU patients with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease.
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CHMP adopts positive opinion for haemophilia B gene therapy
Gene therapy etranacogene dezaparvovec has been granted a positive opinion by the CHMP as a haemophilia B treatment for adults in Europe.
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European Commission approves first medicine for prurigo nodularis
Dupixent®, the first and only targeted medicine for prurigo nodularis has been approved by the EC for adults with a moderate-to-severe form of the condition.
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European Commission approves Pluvicto® for prostate cancer
The European Commission has approved Pluvicto® as the first targeted radioligand therapy for advanced prostate cancer, based on significant results from the Phase III VISION trial.
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Comirnaty® authorised for patients six months to four years
Comirnaty® has been authorised by the MHRA as a vaccine to protect against Covid-19 for individuals from six months to four years old.
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First paediatric EC approval of HIV drug
The European Commission has granted the first paediatric marketing authorisation for Gilead's low-dose Biktarvy® HIV tablet.
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Framework to enable re-use of patient clinical data
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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EC approves Libtayo® for metastatic cervical cancer
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.
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First oral treatment approved for post-transplant refractory cytomegalovirus
The EC has authorised the first UL97 protein kinase inhibitor for adults with post-transplant refractory cytomegalovirus infection.
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EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)
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.
