Lea Eslava-Kim, PharmD

Most Recent Articles by Lea Eslava-Kim, PharmD

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).

FDA Accepts NDA for Glaucoma Drug Rhopressa

By May 15, 2017

The FDA has completed its initial 60-day review of the New Drug Application (NDA) for Rhopressa (netarsudil; Aerie) 0.02% and determined that it's sufficiently complete to permit a substantive review.

More Articles by Lea Eslava-Kim, PharmD