Lea Eslava-Kim, PharmD

Most Recent Articles by Lea Eslava-Kim, PharmD

Novel Reversal Agent for Factor Xa Inhibitors Under FDA Review

By Aug 17, 2017

The FDA has accepted for review the BLA resubmission for AndexXa (andexanet alfa; Portola) for the reversal of the anticoagulant effects of Factor Xa inhibitors in patients experiencing uncontrolled or life-threatening bleeding.

Biologic for Migraine Prevention Submitted to FDA

By May 18, 2017

Amgen announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for erenumab for the prevention of migraines.

Neuroactive Steroid Gets Fast Tracked for Major Depressive Disorder

By May 18, 2017

The Food and Drug Administration (FDA) has granted Fast Track designation to SAGE-217 (Sage Therapeutics) for the potential treatment of major depressive disorder (MDD).

Novel Hemophilia A Gene Therapy Gets Fast Track Status

By May 16, 2017

The Food and Drug Administration (FDA) has granted Fast Track designation to SB-525 (Sangamo Therapeutics) for the treatment of hemophilia A.

Inotersen Shows Promise in Phase 3 Familial Amyloid Polyneuropathy Study

By May 15, 2017

Ionis announced positive results from the Phase 3 study of inotersen (IONIS-TTRRx) for the treatment of familial amyloid polyneuropathy (FAP), now referred to as hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN).

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