Pfizer/Eyetech Macugen Filing Complete; NDA Is Part Of FDA’s “Pilot 1”
The wet age-related macular degeneration product will have a mid-December user fee date; an advisory committee is set for August. The NDA was submitted in “reviewable units” under FDA’s pilot program.
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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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