Keeping Track: An Approval For Ajovy, A CRL For Ruconest, And Some Submissions from J&J
The latest drug development news and highlights from our US FDA Performance Tracker.
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Acadia's Nuplazid Hits A Review Roadblock, But Not A CRL (For Now)
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.
Acadia’s Nuplazid Shows Nearly Three-Fold Reduction In Psychosis Relapse
Data presented at the CTAD meeting for pimavanserin in dementia-related psychosis will support an sNDA filing in 2020 for an approval that could broaden the drug’s market exponentially.
Prevnar 13 Loses ‘Routine’ Endorsement For Older Adults In CDC Panel Vote
ACIP still supports use of Pfizer’s pneumococcal vaccine in immunocompetent individuals ages 65 years and older based on shared clinical decision-making, but concludes that routine immunization is no longer warranted due to herd effect from pediatric vaccination.