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FDA Approves Keytruda (pembrolizumab) as First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature

May 23, 2017 — The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based… Read More..

May 22nd, 2017

Sanofi and Regeneron Announce FDA Approval of Kevzara (sarilumab) for Rheumatoid Arthritis

PARIS and TARRYTOWN, N.Y., May 22, 2017 /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) approval of Kevzara (sarilumab) for the treatment of adult patients with moderately to… Read More..

May 22nd, 2017

FDA Approves Actemra (tocilizumab) Subcutaneous Injection for Giant Cell Arteritis

May 22, 2017 — The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type… Read More..

May 21st, 2017

FDA Approves Merck’s Keytruda (pembrolizumab) for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE) May 18, 2017 –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 two new indications for Keytruda (pembrolizumab), the… Read More..

May 17th, 2017

FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis

May 17, 2017 — The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication… Read More..

May 17th, 2017
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