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FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease

March 21, 2017 — The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An… Read More..

March 21st, 2017

FDA Approves Juvéderm Vollure XC for Correction of Facial Wrinkles and Folds in Adults

DUBLIN, March 20, 2017 /PRNewswire/ — Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market Juvéderm Vollure™ XC, for… Read More..

March 20th, 2017

Array BioPharma Announces Withdrawal of NDA for Binimetinib Monotherapy for the Treatment of NRAS-Mutant Melanoma

BOULDER, Colo., March 19, 2017 /PRNewswire/ — Array BioPharma Inc. (Nasdaq: ARRY) today announced that it has withdrawn from the U.S. Food and Drug Administration’s (FDA) Division of Oncology Products 2 its new drug application (NDA) for… Read More..

March 18th, 2017

AstraZeneca Receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for Hyperkalemia

March 17, 2017 — AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate). Sodium zirconium… Read More..

March 16th, 2017

FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL)

KENILWORTH, N.J. March 14, 2017 –(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1… Read More..

March 14th, 2017
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