FDA OKs new insulin biosimilar for type 2 diabetes
By
Alicia Lasek
Jul 30, 2021
Semglee is a safe and more cost-effective alternative to the drug Lantus (insulin glargine), the agency announced Wednesday. Semglee does not need a prescriber’s input to be substituted at the pharmacy.
FDA OKs third antibody COVID therapy; variants spur new pause on another
By
Alicia Lasek
Jun 01, 2021
A new COVID-19 treatment made by GlaxoSmithKline now is the third monoclonal antibody therapy federally authorized to help prevent severe disease outcomes in high-risk patients. But gene variants are interfering...
Drug that targets Alzheimer’s inflammation approved for trial by FDA
By
Alicia Lasek
Feb 09, 2021
An experimental drug meant to treat the “type 3 diabetes” that some scientists believe triggers Alzheimer’s has been approved for a late-stage clinical trial.
Ambien alternative? FDA approves insomnia drug that improves sleep in seniors
By
Alicia Lasek
Jan 01, 2020
New insomnia medication lemborexant compared favorably to an extended release form of Ambien in a late-stage clinical trial.
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 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 approves extended-release opioid painkiller
By
Elizabeth Newman
Nov 21, 2014
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.
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 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...