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EC Mandates Timely Implementation of EUDAMED Modules
Key TakeawaysManufacturers must register early to avoid compliance issues.
Notified Bodies face stricter deadlines for certificate submissions.
Failure to register devices within the...
Kisqali Approved by European Commission to Cut Breast Cancer Recurrence Risk
Key TakeawaysNearly double the number of eligible early breast cancer patients in Europe
Significant reduction in recurrence risk enhances long-term survival prospects
Kisqali's...
AbbVie Launches ELAHERE in Europe to Treat Resistant Ovarian Cancer
Key TakeawaysELAHERE offers a targeted therapy option, potentially improving survival outcomes for FR-positive, platinum-resistant ovarian cancer patients.
The VENTANA FOLR1 assay facilitates precise...
Key TakeawaysHealthcare providers can incorporate OPUVIZ as a reliable and cost-effective alternative to Eylea, expanding treatment options for patients.
Patients may benefit from...
EU Approves Fasenra for Eosinophilic Granulomatosis with Polyangiitis Treatment
Key TakeawaysFasenra (benralizumab) gains EU approval for treating eosinophilic granulomatosis with polyangiitis (EGPA), providing a new option for patients.
The approval is based...
The approval of the daratumumab-based quadruplet regimen by the European Commission marks a significant advancement in the treatment of newly diagnosed multiple myeloma for...
Dry Eye Disease Treatment Advances with EU Approval of Vevizye® for Moderate to Severe Cases
Key TakeawaysNovaliq and Laboratoires Théa announced that Vevizye® has been approved by the European Commission for the treatment of moderate to severe dry...
Key TakeawaysSmall cell lung cancer patients in Europe may soon have access to HANSIZHUANG (serplulimab), the first anti-PD-1 monoclonal antibody for first-line treatment...
Key TakeawaysOtulfi®, Fresenius Kabi's ustekinumab biosimilar, has received European Commission approval for both subcutaneous and intravenous formulations, expanding treatment options for patients with...
Alagille Syndrome: Ipsen Secures EU Approval for New Treatment Option
Key TakeawaysAlagille syndrome is a rare liver disease that causes severe itching due to bile flow issues.
Ipsen’s Kayfanda (odevixibat) is now approved...
Most Recent Market Recall of Cosmetic Products Due to Chemical Risk
Key TakeawaysThe European Commission has recalled certain batches of cosmetic products due to chemical risks associated with BMHCA.
This substance, banned in cosmetics,...
License Reprieve: Advanz Secures Temporary Suspension on EU Revocation of Ocaliva
Key TakeawaysAdvanz Pharma has successfully secured a suspension from the General Court of the European Union, temporarily halting the European Commission's decision to...
Key TakeawaysThe European Commission has approved the combination of KEYTRUDA and Padcev as a first-line treatment for adults with unresectable or metastatic urothelial...
Moderna’s mRESVIA Vaccine Approved by European Commission for RSV
Key Takeaways:Moderna’s mRESVIA vaccine has received European Commission approval for protecting adults aged 60+ against RSV.
The approval is based on robust clinical...
EU Launches €35 Million Initiative to Enhance Joint Health Technology Assessments
The European Health and Digital Executive Agency (HaDEA) has unveiled a significant procurement project aimed at advancing joint health technology assessments (HTA) and scientific...
