Genentech has made history in the US as the first company to have a Food and Drug Administration-designated breakthrough therapy gain market approval. The product is Gazyva (obinutuzumab/GA101), which has won approval in combination with chlorambucil as a therapy for treatment-naïve chronic lymphocytic leukemia (CLL)1.
Genentech has made history in the US as the first company to have a Food and Drug Administration-designated breakthrough therapy gain market approval. The product is Gazyva (obinutuzumab/GA101), which has won approval in combination with chlorambucil as a therapy for treatment-naïve chronic lymphocytic leukemia (CLL)1.
San Francisco-based Genentech gained the FDA’s nod well-ahead of the 20 December goal date for the biologics license application (BLA),...
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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