Dordaviprone under FDA priority review for aggressive glioma type
The U.S. Food and Drug Administration (FDA) has agreed to a priority review of a Chimerix application seeking accelerated approval of dordaviprone, its oral…
priority review
Sarclisa under FDA priority review as first-line myeloma therapy
The U.S. Food and Drug Administration (FDA) has granted priority review to Sanofi’s application of Sarclisa (isatuximab) in combination with standard of care for…
Ide-cel Granted FDA Priority Review for Heavily-treated Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted priority review to Bristol Myers Squibb and Bluebird Bio‘s application requesting the approval of…
Melflufen Combo Earns FDA Priority Review for Triple-refractory Myeloma
The U.S. Food and Drug Administration (FDA) has granted priority review to Oncopeptide’s application seeking accelerated approval of melflufen (melphalan flufenamide) plus dexamethasone…
FDA Grants Priority Review to Belantamab Mafodotin for Heavily-treated Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted priority review status to GlaxoSmithKline‘s application seeking the approval of belantamab mafodotin for the treatment of heavily…
FDA Grants Priority Review to Darzalex Combo for Transplant-eligible Patients
The U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) of Darzalex (daratumumab)…
Selinexor Granted Priority Review by FDA for Heavily Treated Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted priority review to Karyopharm Therapeutics’ application requesting accelerated approval of its investigational therapy selinexor as…
FDA Grants Priority Review to Empliciti Combo Therapy for Relapsed or Refractory Myeloma
The U.S. Food and Drug Administration granted priority review to Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) combined with Pomalyst (pomalidomide) and…
FDA to Give Priority Review to Darzalex Combinations for Multiple Myeloma
The U.S. Food and Drug Admnistration will give priority review to Darzalex (daratumumab) as an add-on to standard treatments for multiple myeloma patients who cannot…
