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.
CHMP | 15/11/2025 | By Dineshwori | 122
Dr. Reddy's Receives Positive CHMP Opinion from European Medicines Agency for Denosumab
Dr. Reddy’s Laboratories has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, a proposed biosimilar to Prolia and Xgeva, moving it closer to potential marketing authorisation in the European Economic Area (EEA).
CHMP | 24/09/2025 | By Dineshwori
AbbVie Gets Positive CHMP Opinion for Mirvetuximab Soravtansine
AbbVie has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of mirvetuximab soravtansine (ELAHERE).
CHMP | 21/09/2024 | By Aishwarya | 469
Aurobindo Pharma Ltd's subsidiary to withdraw application for EU Marketing Authorization of two biosimilars
CHMP | 26/06/2023 | By Sudeep Soparkar | 861
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