Alere Inc. has announced its Alere™ i RSV test received 510(k) marketing clearance from the FDA.
In one of the sadder coincidences of my life, news of an FDA-approved cartilage implant made me more excited than it would have a year ago. That’s because this particular synthetic cartilage implant is for those with osteoarthritis in their big toe, and I happened to be diagnosed this summer with arthritis in my toes.
The nation’s leading consumer watchdog is asking the Food and Drug Administration to prohibit direct-to-consumer diabetes drug advertising promoting unapproved off-label benefits like weight and blood pressure reduction.
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 diabetic macular edema.
Despite opposition from some drug makers and provider groups, Illinois lawmakers are considering several bills that would allow terminal patients to try unapproved experimental drugs to extend their lives.
Government investigators are calling for greater scrutiny of antipsychotics use among dementia patients in post-acute settings beyond nursing homes.