Servier Announces FDA Filing Acceptance and Priority Review for TIBSOVO® (ivosidenib tablets) in the Treatment of IDH1-mutated Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS) If approved, TIBSOVO will be the first and only approved targeted therapy for MDS patients with a susceptible IDH1 mutat.
Servier Announces FDA Filing Acceptance and Priority Review for TIBSOVO® (ivosidenib tablets) in the Treatment of IDH1-mutated Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS) streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
The FDA has granted priority review to the supplemental new drug application seeking the approval of ivosidenib for the treatment of patients with IDH1-mutated, relapsed/refractory myelodysplastic syndrome.
The approval of ELREXFIO is based on clinically meaningful response rates and duration of response from Phase 2 MagnetisMM-3 study
ELREXFIO is the first off-the-shelf fixed-dose subcutaneous. -Today at 02:09 pm- MarketScreener
FDA Fast-Tracks Pfizer s ELREXFIO for Multiple Myeloma miragenews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from miragenews.com Daily Mail and Mail on Sunday newspapers.