Drug Approval | June 27, 2023
Moderna files for FDA authorization of its Covid-19 Vaccine
Supply readiness follows months of manufacturing to ensure timely and ample supply
Supply readiness follows months of manufacturing to ensure timely and ample supply
The company will supply materials to all global regions including Asia such as China, India, Europe, and the U.S.
This product will be manufactured at Lupin's Pithampur facility in India
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.
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
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
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
Convergent action on AMR identified as an important area of intervention
The inspection closed with zero observations
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