FDA Approvals - Lexicon Files Investigational New Drug Application For LX1032 As A
Lexicon Files Investigational New Drug Application For LX1032 As A Potential Treatment For Carcinoid Syndrome (Medical News Today)
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for LX1032, an oral drug candidate for managing gastrointestinal symptoms associated with carcinoid syndrome. [click link for full article]
First-time generics get US boost (Business Standard India)
Indian pharmaceutical companies led by Ranbaxy Laboratories have bagged 20 first-time generic approvals from the US Food and Drug Administration (FDA) in the eleven months from January to November this year, which constitutes about a quarter of the total 81 approvals given in this period.
AMAG Pharmaceuticals, Inc. Submits New Drug Application To FDA For Ferumoxytol In Chronic Kidney Disease Patients (Medical News Today)
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for marketing approval of ferumoxytol as an intravenous treatment of iron deficiency anemia in patients with chronic kidney disease (CKD), including dialysis dependent and non-dialysis dependent patients. [click link for full article]