[Blood sample for hemophilia test, inherited genetic bleeding disorder] Md Saiful Islam Khan/iStock via Getty Images * The USA FDA has extended its review of Novo Nordisk's (NVO [https://seekingalpha.com/symbol/NVO]) BLA seeking approval of denecimig for hemophilia A. * The Danish pharma said that ongoing facility remediation activities at a manufacturing site for the drug are the reason for the delay. * Novo noted that the agency did not identify any issues with clinical trial data used to support its application. * Although the FDA didn't say when a decision on the BLA would come down, Novo said it is anticipating [https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=917287] a US launch in H1 2027.
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