COVID-19
The Food and Drug Administration (FDA) is redefining its approach to COVID-19 vaccine approval, shifting its focus towards prioritizing high-risk groups, including older adults and those with certain health conditions. This change marks a significant shift in the agency's strategy, narrowing the scope of vaccine eligibility to those
Diseases
The US Food and Drug Administration (FDA) has approved IMAAVY (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). This approval follows the FDA's Priority Review designation and offers a new treatment option in a proven class with the potential for lasting disease
Diseases
The U.S. Food and Drug Administration has cleared the Lumipulse G pTau217/È-Amyloid 1-42 Plasma Ratio for marketing, a device that tests blood to aid in diagnosing Alzheimer's disease. This marks a significant step forward in the early detection and diagnosis of the disease, which affects more
Diseases
U.S. health officials have endorsed the first blood test that can help diagnose Alzheimer's and identify patients who may benefit from drugs that can modestly slow the memory-destroying disease. The test, developed by Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a
Cable News Network
As the Department of Health and Human Services (HHS) considers stopping routine Covid vaccine recommendations for children, teens, and pregnant women, former FDA Commissioner Dr. Robert Califf shares his thoughts on the matter. In a CNN News Central interview, Califf discusses the changing landscape of the pandemic and the importance
Diseases
The US Food and Drug Administration (FDA) has given marketing clearance to a blood test that can aid in the early detection of Alzheimer's disease, the first of its kind to receive signoff in the United States. Developed by Fujirebio Diagnostics Inc., the test measures two proteins in
Cable News Network
A report by the organization Healthy Babies, Bright Futures found that samples of store-bought rice from over 100 brands in the US contain high levels of arsenic and cadmium, which can have serious health consequences, especially for young children. The report, which analyzed rice purchased in the US, found that
Diseases
Cure Rare Disease, a clinical-stage nonprofit biotechnology company, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational anti-sense oligonucleotide therapeutic for the treatment of Spinocerebellar Ataxia (SCA), including Spinocerebellar Ataxia Type 3 (SCA3). This designation acknowledges the significant unmet medical
Cable News Network
At least 10 people in the U.S. have been hospitalized with listeria infections linked to ready-to-eat foods produced by Fresh & Ready Foods LLC of San Fernando, California. The Food and Drug Administration (FDA) and other agencies traced the outbreak to the recalled products, which were sold in Arizona,
Cable News Network
The US Food and Drug Administration is starting the process to remove prescription fluoride tablets and drops from the market, citing concerns over the mineral's potential health impacts, particularly on the gut microbiome and thyroid function. This move follows recent guidance from Utah's state health officials
Drug approval
The U.S. Food and Drug Administration has approved AbbVie's Vyalev, an infusion-based treatment for Parkinson's disease that provides a continuous source of levodopa/carbidopa, increasing "on" time and reducing motor fluctuations. This innovative delivery method, similar to insulin therapy for diabetes, has been
United States. Food and Drug Administration
The Department of Health (DOH) in the Philippines has issued a warning against individuals and groups offering Mpox vaccines that are not approved by regulatory agencies, emphasizing the importance of waiting for legitimate and safe vaccination options. Mpox, a viral disease that can cause skin rashes and mucosal lesions, is
