TAP Uprima Erectile Dysfunction NDA Refiling Slated For 4Q, Abbott Says
TAP will refile an NDA for the erectile dysfunction disorder drugUprima in the fourth quarter, Abbott Pharmaceuticals President Jeff Leiden, MD/PhD, told analysts on a first quarter conference call April 9
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It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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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.
