Nuplazid Complete Response Letter For Dementia Psychosis Driven By Effectiveness Concerns In Subgroups
Acadia says the US FDA’s view has shifted from what was previously agreed upon for approval of an sNDA for pimavanserin in a broad dementia-related psychosis indication.
You may also be interested in...
Keeping Track: Cloudy Horizon For Teplizumab, Roxadustat; Nuplazid Stumbles Over Subgroups; CAR-T Submissions From Gilead, J&J
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Deficiencies identified by the US FDA could delay the approval of pimavanserin for hallucinations associated with dementia-related psychosis, but Acadia did not have details for investors.
The company is requesting FDA expand the antibody cocktail to include a COVID prevention claim with a lower 1,200mg dose and a subcutaneously administered formula.