#fda-approval

#fda-approval

US regulators on Monday gave the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication to treat obesity. The US Food and Drug Administration's approval handed drugmaker Novo Nordisk an edge over rival Eli Lilly in the race to market an obesity pill. Lilly's oral drug, orforglipron, is still under review. Both pills are GLP-1 drugs that work like widely used injectables to mimic a natural hormone that controls appetite and feelings of fullness.

U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido, saying the once-a-day pill can now be taken by postmenopausal women up to 65 years old. The announcement Monday from the Food and Drug Administration broadens the drug's use to older women who have gone through menopause. The pill, Addyi, was first approved 10 years ago for premenopausal women who report emotional stress due to low sex drive.

Malmö-based Flow Neuroscience 's revolutionary at-home brain stimulation device for the treatment of depression has already been adopted in clinics across the UK, Europe, and beyond, and helped over 55,000 users. Now It's coming to the US in Q2 of next year. Flow Neuroscience recently announced FDA approval of their breakthrough Flow at-home brain-stimulation device for the treatment of major depressive disorder (MDD).

Paradromics is one of several companies-which include Neuralink, Synchron, Precision Neuroscience, and Cognixion-working on technology to control computers and other devices using brain waves. Known as brain-computer interfaces, or BCIs, these systems capture brain signals associated with movement intention and translate them into commands. The Paradromics study is slated to begin early next year and include two individuals. After collecting data on the first two participants for a year, the company plans to ask the FDA to expand the study to include more volunteers.

The US Food and Drug Administration has approved a blood test to aid in the diagnosis of Alzheimer's disease - the second such test and the first cleared for use in primary-care settings, such as a doctor's office. The test measures Alzheimer's-related proteins to rule out the disease in people with cognitive decline. Last week, pharma company Roche announced that the test was correctly able to rule out Alzheimer's 97.9% of the time.

According to Martin Makary, head of the US Food and Drug Administration (FDA), the drug leucovorin will help hundreds of thousands of kids with autism. But a day after Makary praised leucovorin's powers at a White House event, some specialists are warning that the science to warrant Makary's enthusiasm is far from solid. Those researchers say that the drug's efficacy has not been established, that scientists don't know how much of the drug to give or how people should take it, and that safety data in children are lacking.

"Waist circumference, blood pressure, LDL cholesterol, resting heart rate - they are much better measures of how healthy someone is than glucose," the University of Oxford's Nicola Guess told The Atlantic.

Wildtype's salmon is not a plant-based meat alternative; it's actual salmon, derived from Pacific salmon cells that have been fed with nutrients like protein, fat, and salt.

The approval of lenacapavir, requiring a twice-yearly injection, represents a significant leap in HIV prevention efforts, especially improving compliance over daily pill regimens.

"Even a single FMT will cause a change in the host-microbe relationships in these very different regions of the bowel that may be very difficult to reverse."

Butterfly pea flower extract, used for centuries in various cultures for its vibrant color, has been approved by the FDA as a natural food coloring option.

It is estimated that 700,000 Americans are currently afflicted with alopecia areata, with rates higher in minority communities, showcasing the urgent need for effective treatments.

"The pain always travels in some way, and it's undeniably overwhelming," explained Terri Battenburg. "I usually just try to power through it, but it's like trying to swim through mud."

With full FDA approval, Novavax would have permission to keep its shot on the market indefinitely, as emergency authorization can be revoked after a health emergency.