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    SOBI — Swedish Orphan Biovitrum AB (publ) News Story

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    Brief: SOBI Receives Complete Response Letter From FDA For NASP

    Picture of Swedish Orphan Biovitrum AB (publ) logoSwedish Orphan Biovitrum AB (publ)
    26/06/2026 20:19
    BRIEF-SOBI Receives Complete Response Letter From FDA For NASP
    June 26 (Reuters) - Swedish Orphan Biovitrum AB (publ) SOBIV.ST:
    • SOBI RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR NASP (NANOENCAPSULATED SIROLIMUS PLUS PEGADRICASE)
    • SWEDISH ORPHAN BIOVITRUM - FDA REQUESTS ADDITIONAL MANUFACTURING DATA AND FACILITY DEFICIENCIES ADDRESSED FOR NASP
    • SWEDISH ORPHAN BIOVITRUM - SOBI TO MEET WITH FDA TO DISCUSS NASP RESUBMISSION
    Source text: ID:nWkr8yBKgg
    Further company coverage: SOBIV.ST

     ((Reuters.Briefs@thomsonreuters.com;))

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