Drug Approval | December 06, 2024
FDA accepts supplemental Biologics License Application for Roche’s Columvi combination
For people with relapsed or refractory diffuse large B-cell lymphoma
For people with relapsed or refractory diffuse large B-cell lymphoma
New research labs and process development services to enable next generation therapeutics
Performed within GENEWIZ from Azenta Life Sciences' CLIA-certified and CAP-accredited state-of-the-art clinical genomics laboratory
Bringing a new drug to market takes about 10 years and requires an investment of approximately $1 billion
CMG1A46 is an investigational T cell-engager with potential to deeply deplete uncontrolled B cells present in autoimmune diseases such as lupus
Efficacy and safety from this phase IV study were consistent with data from the Vabysmo phase III DME studies
Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w
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
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