CDSCO, NRAI meets WHO international standards for vaccine regulations
India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI
India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI
The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease
Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings
India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma
The Lilly Medicine Foundry is set to drive innovation in drug production and make medicines for clinical trials
Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun
The company will also share results in two additional posters for deuruxolitinib
Pfizer's decision is based on the totality of clinical data
This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II
New Phase II data show vast majority of patients experiencing no relapses or disability progression
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