News from the FDA/CDC
News
FDA clears new biomarker assays for early Alzheimer’s detection
Currently, the only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scans.
News from the FDA/CDC
CDC signs off on RSV vaccine for older adults
The vote recommending shared decision making about the vaccine, instead of a routine vaccination recommended for all, “is a weaker recommendation...
News from the FDA/CDC
Severe strep infections rebound after pandemic lull
These infections fell by 25% during the COVID-19 pandemic and were especially low in children.
News from the FDA/CDC
FDA OKs low-dose colchicine for broad CV indication
“The FDA approval of colchicine for patients with atherosclerotic disease is a huge signal that physicians need to be aware of inflammation as a...
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-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
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.