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Lupin Secures Positive CHMP Opinion for Ranibizumab Biosimilar
Lupin has received a positive opinion from the CHMP for its ranibizumab biosimilar, supported by comprehensive analytical similarity data and a global Phase III clinical trial involving 600 patients with neovascular Age-related Macular Degeneration (AMD).
Committee For Medicinal Products For Human Use | 18/12/2025 | By News Bureau
CHMP Recommends Sanofi's Tezeild for EU Approval in Stage 2 Type 1 Diabetes
The CHMP has backed EU approval for Sanofi’s Tezeild, supported by TN-10 study results showing the therapy can delay progression to stage 3 type 1 diabetes in patients with stage 2 disease. If authorised, Tezeild would become the first disease-modifying treatment for T1D in the EU.
Committee For Medicinal Products For Human Use | 15/11/2025 | By Dineshwori | 194
Novo Nordisk Expects EC Approval of Alhemo Label Update for Haemophilia in 2 Months
Novo Nordisk has received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP) for expanded Alhemo use in haemophilia without inhibitors.
Committee For Medicinal Products For Human Use | 26/07/2025 | By Dineshwori | 306
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