News from the FDA/CDC
News from the FDA/CDC
FDA approves first-ever OTC erectile dysfunction gel
Futura Medical has not announced when it will be available in the United States.
News from the FDA/CDC
Sewer data says Ohio person has had COVID for 2 years
“Unusual or ‘cryptic’ sequences identified in wastewater may represent viruses that can replicate in particular individuals, but not in the...
News from the FDA/CDC
FDA approves first treatment for constipation in children
SBM frequency improved during the first week and was maintained throughout the remainder of the 12-week treatment period.
News
FDA panel unanimously endorses lecanemab for Alzheimer’s
An intravenous infusion targeting amyloid-beta, lecanemab received accelerated FDA approved earlier in 2023 for the treatment of early Alzheimer’s...
News from the FDA/CDC
FDA warns people to avoid compounded semaglutide medicines
“Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products...
News from the FDA/CDC
FDA approves new drug, sotagliflozin, for heart failure
“It will be a reasonably tall task for sotagliflozin to come from behind and be disruptive in a space where there are already two well-established...
News from the FDA/CDC
FDA approves buprenorphine injection for opioid use disorder
Brixadi is approved in both weekly and monthly subcutaneous injectable formulations at varying doses.
News from the FDA/CDC
FDA approves Yuflyma as ninth adalimumab biosimilar
The manufacturer Celltrion is also seeking an interchangeability designation from the FDA, tentatively expected in the fourth quarter of 2024.
News from the FDA/CDC
FDA approves autoinjector pen for Humira biosimilar, Cyltezo
The drug will be commercially available on July 1, 2023.
News from the FDA/CDC
FDA clears iLet bionic pancreas insulin delivery system
Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large...
News from the FDA/CDC
Overdose deaths mark another record year, but experts hopeful
“But these numbers are still extraordinarily high. We shouldn’t suggest the crisis is in any way over.”