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FDA application process
Pharma
Novo cites production site corrections amid hemophilia FDA delay
The FDA's review is still ongoing, with no new timeline communicated, as Novo works through some production plant remediation work.
Fraiser Kansteiner
Oct 5, 2026 7:15am
Novo’s Catalent plant ditched in FDA refiling of SMA drug
Aug 10, 2026 10:06am
Incyte's Opzelura slapped with vitiligo decision delay
Mar 14, 2022 11:28am
