FDA delays review of Novo's hemophilia A drug denecimig over factory issues
read at Endpoints ↗RegulatoryNegative
US regulators have extended the review of Novo's hemophilia A injection, denecimig, because of problems at an unnamed manufacturing facility.
The FDA said ongoing remediation activities observed during a pre‑license inspection were the reason for the delay.
The postponement adds uncertainty to Novo's timeline and may affect investors awaiting the drug's approval.
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This writeup was produced by pharmadog from original reporting by Endpoints.
Original headline: “FDA delays Novo’s hemophilia A drug review over factory issues”
read at Endpoints ↗81 words · retrieved 1h ago
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