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 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.
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...
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.
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 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.
Lawmakers push FDA to take swift action on OTC hearing aids
By
Diane Eastabrook
Apr 12, 2022
A bipartisan team has introduced a bill that orders the FDA to stop dragging its feet and issue a final rule making over-the-counter hearing aids available to consumers.
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...