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News about "European Commission Approval"
Pfizer Secures EC Approval to Expand Hympavzi Use for Haemophilia Patients with Inhibitors
Pfizer has secured European Commission approval to expand the use of Hympavzi for haemophilia A and B patients with inhibitors, offering a once-weekly subcutaneous treatment option designed to reduce bleeding episodes and improve disease management.
European Commission Approval | 14/05/2026 | By News Bureau
Bristol Myers Squibb Secures EC Approval for Sotyktu in Psoriatic Arthritis
Bristol Myers Squibb receives European Commission (EC) approval for Sotyktu to treat active psoriatic arthritis in adults, marking the EU’s first approved TYK2 inhibitor for this indication.
European Commission Approval | 12/05/2026 | By News Bureau
Henlius and Organon Win EC Nod for POHERDY, Biosimilar to PERJETA
European Commission (EC) approves Shanghai Henlius Biotech Inc. and Organon & Co.’s POHERDY (pertuzumab), the first PERJETA biosimilar in Europe, backed by strong analytical, clinical, safety, and immunogenicity data.
European Commission Approval | 30/04/2026 | By News Bureau | 111
European Commission Approves Needle-Free Adrenaline Nasal Spray for Children with Severe Allergies
ALK’s EURneffy 1 mg expands access to needle-free emergency treatment for anaphylaxis in children aged 4 and above across the EU.
European Commission Approval | 02/04/2026 | By News Bureau
EU Grants Conditional Approval to Rezurock for Chronic GVHD Treatment
European Commission authorises belumosudil for patients aged 12 plus with limited treatment options, marking a significant advance in managing a life-threatening post-transplant condition.
European Commission Approval | 01/04/2026 | By News Bureau
Lupin Secures European Commission Approval for Ranluspec, Biosimilar Ranibizumab
European Commission clears Lupin’s biosimilar ranibizumab, Ranluspec, for multiple retinal disorders; Sandoz to commercialise across the EU, expanding access to affordable biologics.
European Commission Approval | 24/02/2026 | By News Bureau | 125
European Commission Expands GSK's RSV Vaccine Arexvy to Adults Aged 18 and Above
GSK’s RSV vaccine Arexvy receives European approval for adults aged 18 plus, marking a major expansion in protection against RSV-related respiratory illness across the region.
European Commission Approval | 28/01/2026 | By News Bureau | 135
European Commission Approves Sobi's Aspaveli for Rare Kidney Diseases C3G and IC-MPGN
The European Commission has approved Sobi’s Aspaveli for adolescents and adults with rare kidney diseases C3G and IC-MPGN, marking the first approved therapy for these conditions.
European Commission Approval | 19/01/2026 | By News Bureau | 195
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