News from the FDA/CDC
News from the FDA/CDC
FDA panel backs new COVID booster focusing only on variants
Panelists also raised other questions during the meeting, including concerns about moves toward tying COVID vaccinations into the model of annual...
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 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
FDA moves to curb misuse of ADHD meds
The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.
Conference Coverage
New drugs in primary care: Lessons learned from COVID-19
Nirmatrelvir-ritonavir has helped keep many patients out of the hospital, says internist.
News from the FDA/CDC
CDC backs FDA’s call for second COVID booster for those at high risk
The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP).
News from the FDA/CDC
Most adults, more than one in three children take dietary supplements: Report
Women and girls were more likely to take supplements than men and boys.
News from the FDA/CDC
Single bivalent COVID booster is enough for now: CDC
Booster strength wanes after a few months, spurring discussions of whether people at high risk of getting a severe case of COVID may need more...
News from the FDA/CDC
FDA approves OTC naloxone, but will cost be a barrier?
“The major question is what is it going to cost. In order for people to access it they have to be able to afford it,”