Drug Approval | November 21, 2025
Merck receives EU nod for first subcutaneous formulation, promising faster cancer treatment
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
Prolia is a prescription medicine used to treat osteoporosis in women
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission
Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision
European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)
The agency concluded that for people of all ages, IXCHI should be administered when there is a significant risk of chikungunya infection
The Medical Countermeasures Strategy focuses on strengthening the EU’s preparedness for health crises
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