Genzyme Will Act Fast To Design Post-Market Myozyme Study By Review Date
The on-time approval of a larger production scale of Genzyme's Pompe Disease biologic Myozyme could hinge on development of a post-market study protocol prior to the Nov. 29 PDUFA date
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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.’
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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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