Tag Archives: approves

FDA Approves Emgality (galcanezumab-gnlm) for the Treatment of Episodic Cluster Headache

Print this page INDIANAPOLIS, June 04, 2019 – Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Emgality (galcanezumab-gnlm) injection (300 mg) for the treatment of episodic cluster headache in adults.1 Emgality is an innovative therapeutic approach for this neurologic disease and the first and only… Read More »

FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions

FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions Print this page May 01, 2019 — The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in… Read More »

FDA Approves Ibrance (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer

Print this page April 4, 2019 — Pfizer (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indications for Ibrance (palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-)… Read More »