The FDA has agreed to review a supplemental marketing application from AbbVie (NYSE:ABBV) related to the use of Imbruvica (ibrutinib) and Roche’s (OTCQX:RHHBY) Rituxan (rituximab) to treat Waldenström’s macroglobulinemia, a rare and incurable type of non-Hodgkin lymphoma (NHL).
The filing seeks to update Imbruvica’s U.S.
prescribing information based on an analysis of more than five years of
data from the Phase 3 INNOVATE study.
Related ticker: Johnson & Johnson (NYSE:JNJ)
https://seekingalpha.com/news/3585322-fda-to-review-abbvie-application-to-update-imbruvica-labeling
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