FDA

FDA approves OraSure’s at-home HIV test

OraQuick is an at-home HIV test - a version of the company's lab-based diagnostic, and, using an oral swab, it can detect antibodies of HIV-1 and HIV-2 in about 20 minutes, according to the company. Assuming the device sells for $40 a unit, it could bring in about $20 million in sales by next year, [...]

July 13th, 2012|News|

FDA Approval For Melafind

MELA Sciences MELA today announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter for the MelaFind(R) Pre-Market Approval (PMA) application. The company intends to work with the agency to finalize the physician and patient labeling, package insert, user's guide, training program and clinical protocol for a post-approval study in order [...]

September 27th, 2011|News|

Orexigen and FDA Identify a Clear and Feasible Path to Approval for Contrave

SAN DIEGO, Sept. 20, 2011 /PRNewswire via COMTEX/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX) announced today that following a recent meeting with senior officials in FDA's Office of New Drugs (OND), the Company received written correspondence detailing OND's design requirements for a cardiovascular outcomes trial (CVOT) for Contrave® that would address the Complete Response Letter [...]

September 23rd, 2011|News|