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 Eticovo (etanercept-ykro), a Biosimilar to Enbrel (etanercept)

News New Drugs FDA Approves Eticovo (etanercept-ykro), a Biosimilar to Enbrel (etanercept) Print this page April 26, 2019 The FDA has approved Eticovo (etanercept-ykro), a biosimilar to U.S.-licensed Enbrel (etanercept). A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product,… 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 »