New Drug Approvals

New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

FDA Approves Palynziq (pegvaliase-pqpz) for the Treatment of Adults with Phenylketonuria

May 24 2018

May 24, 2018 - The U.S. Food and Drug Administration today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down...

GSK Receives FDA Approval of Arnuity Ellipta for Asthma in Children From 5 Years of Age

May 24 2018

London, UK 21 May 2018 --GSK today announced it has received approval from the US Food and Drug Administration (FDA) for the use of Arnuity Ellipta (fluticasone furoate) a once-daily inhaled corticosteroid (ICS) medicine for the maintenance...

Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer

May 23 2018

MUMBAI & PRINCETON, N.J. & KING OF PRUSSIA, Pa. May 23, 2018 --(BUSINESS WIRE)--Sun Pharmaceutical Industries Ltd. and includes its subsidiaries and/or associate companies) and Churchill Pharmaceuticals, LLC. (Churchill) today announced that...

FDA Approves Doptelet (avatrombopag) for Chronic Liver Disease Patients with Thrombocytopenia who are Undergoing a Medical Procedure

May 21 2018

May 21, 2018 -- The U.S. Food and Drug Administration today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental...

FDA Approves Lokelma (sodium zirconium cyclosilicate) for the Treatment of Adults with Hyperkalemia

May 18 2018

May 18, 2018 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults. Hyperkalemia is a serious condition...

FDA Approves Aimovig (erenumab-aooe) as a Preventive Treatment for Migraine

May 17 2018

May 17, 2018 -- The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive...