The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
This trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable
Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma
Laurus will also provide funding for the clinical trials and will launch these products in India and emerging markets
The inspection closed with the facility receiving an inspection classification of NAI
Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
The inspection closed with zero observations
The company will submit its comprehensive response on these observations to the US FDA
Granules now has a total of 58 ANDA approvals from US FDA
Total investments could reach €70 million, of which approximately 15% in R&D and 85% in capex, that would be deployed from 2026
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