The U.S. Food and Drug Administration gave market clearance to an extended-release opioid painkiller yesterday. It is designed for those with severe pain.
FDA panel approves first biosimilar drug
Mar 10, 2015
The Food and Drug Administration approved its first biosimilar product last week, opening the door for more costly drug alternatives.
FDA alerts providers to lack of sterility in NuVision Pharmacy products
May 21, 2013
The Food and Drug Administration expanded an alert about NuVision Pharmacy of Dallas, TX, on Saturday. It said investigators found poor sterile production practices that raised concern about a lack of...
Accessory for swimming approved for cochlear implants
Apr 22, 2014
The Food and Drug Administration has approved the Aqua+ accessory, a waterproof, behind-the-ear product for cochlear implant recipients. The accessory allows Cochlear™ Nucleus® 5 and Nucleus 6 Implant...
FDA approves first biosimilar treatment
By
Elizabeth Newman
Apr 06, 2015
The Food and Drug Administration approved its first biosimilar product in March, opening the door for more costly drug alternatives.
FDA approves ‘breakthrough’ therapy for diabetic eye disorder
By
John Hall
Mar 26, 2015
The FDA announced Wednesday that it has granted “breakthrough therapy designation” to the drug Eylea, and expanded its approved use for the treatment of diabetic retinopathy in patients with...
FDA wants lower doses for sleeping aids
By
Elizabeth Newman
Feb 01, 2013
The Food and Drug Administration is requiring manufacturers of certain sleeping pills, including the widely prescribed Ambien, to reduce current recommended dosages.