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FDA Approves Mvasi (bevacizumab-awwb), a Biosimilar to Avastin

September 14, 2017 — The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the… Read More..

September 14th, 2017

FDA Approves Aliqopa (copanlisib) for Adults with Relapsed Follicular Lymphoma

September 14, 2017 — The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic… Read More..

September 14th, 2017

Actelion Receives FDA Approval of Tracleer (bosentan) for Use in Pediatric Patients with Pulmonary Arterial Hypertension

SOUTH SAN FRANCISCO, Calif, September 6, 2017 – Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that the U.S. Food and Drug Administration (FDA) has approved a new 32 mg… Read More..

September 6th, 2017

AbbVie Submits New Drug Application to FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain

NORTH CHICAGO, Ill., Sept. 6, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that it has submitted a New Drug… Read More..

September 6th, 2017

FDA Approves Mylotarg (gemtuzumab ozogamicin) for the Treatment of Acute Myeloid Leukemia

September 1, 2017 — The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA… Read More..

September 1st, 2017
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