je.st
news
Tag: designation
Hansa Medical receives FDA Orphan Drug Designation for IdeS
2015-09-15 06:06:51| Appliances - Topix.net
Hansa Medical today announced that the U.S. Food and Drug Administration has granted orphan drug designation to IdeS for the prevention of antibody mediated organ rejection in solid organ transplant patients. More information about the ODD has been posted on www.fda.com Approximately 30 percent of the patients on the waiting lists for kidney, heart, lung and pancreas, equivalent to approximately 35 000 patients in the US, are sensitized to Human Leukocyte Antigen .
Tags: medical
drug
receives
designation
Akcea Therapeutics obtains FDA Orphan Drug Designation for volanesorsen
2015-07-06 15:29:07| Biotech - Topix.net
Akcea Therapeutics, a wholly-owned subsidiary of Isis Pharmaceuticals, Inc. , announced today that the U.S. Food and Drug Administration has granted Orphan Drug Designation to volanesorsen for the treatment of patients with Familial Chylomicronemia Syndrome . FCS is a rare genetic disease characterized by extremely high triglyceride levels and risk of pancreatitis.
Tags: drug
designation
fda
obtains
MM-398 Receiving The Priority Review Designation By US FDA For New Drug Application And The Acceptance Of Market Authorization Application By EMA In Post-Gemcitabine Metastatic Pancreatic Cancer
2015-07-01 08:52:42| drugdiscoveryonline Home Page
PharmaEngine, Inc. (TWO: 4162) announced that (1) its license partner, Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK), has received the notification from the US Food and Drug Administration (FDA) for the acceptance and the grant of the priority review designation for their New Drug Application (NDA); and (2) its sublicense partner, Baxalta Incorporated, a wholly owned subsidiary of Baxter International Inc. (NYSE: BAX) has received the acceptance of Market Authorization Application (MAA) from the European Medicines Agency (EMA), of MM-398 (irinotecan liposome injection, also known as "nal-IRI,") in the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy
Tags: review
market
application
drug
Alnylam Receives Orphan Drug Designation From The United States Food & Drug Administration For Revusiran, An Investigational RNAi Therapeutic For The Treatment Of Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis)
2015-06-03 06:41:56| drugdiscoveryonline Home Page
Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced recently that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to revusiran, an investigational RNAi therapeutic, for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis)
Tags: united
states
united states
food
Susan L. Hartman receives Certified Divorce Financial Analyst designation
2015-05-01 22:45:16| Apparel - Topix.net
Susan L. Hartman, J.D., CPWA, CFP, has been awarded the Certified Divorce Financial AnalystTM designation from The Institute for Divorce Financial AdvisorsTM.
Tags: financial
certified
susan
receives
Sites : [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] next »