Posts Tagged ‘FDA’

Drug development for obesity may well be in a golden age. In large part, this is because the scientific understanding of obesity has grown exponentially in the past two decades. Unfortunately, little or none of that is reflected in new draft guidance from FDA, issued yesterday for public comment, on developing the next generation of […]

This has been quite a year. We’ve seen endless death and destruction in Ukraine and the Middle East. People expressed discontent with the status quo in elections all over the world. But most notably for our readers – more than 100,000 of you this year – the progress on obesity and health has been nothing […]

For the first time in 30 years, FDA has handed the food industry a better tool for marketing their products as “healthy.” But that’s not all. The agency is also working on a seal – an FDA-approved symbol – food marketers can put on their products if they meet the agency’s definition for healthy food. […]

For patients with obesity and sleep apnea, FDA approved a first yesterday. Tirzepatide became the first ever drug with an FDA-approved indication for treating sleep apnea in persons with obesity. The data for this data appeared in the New England Journal of Medicine earlier this year. Atul Malhotra and colleagues found: “In two trials, the […]

Are we indeed reaching the end of the on-again, off-again supply shortage for GLP-1 obesity medicines? That seems to be what FDA signaled yesterday. The agency posted a brief statement, not only noting its determination that the tirzepatide shortage is “resolved,” but also saying the national GLP-1 supply has begun to stabilize. FDA is looking at […]

 Why can’t they just go away? When compounded GLP-1 medicines started showing up two years ago, they seemed like a temporary distraction. In The New Yorker, Jia Tolentino described a dubious concoction of semaglutide she obtained from a compounding pharmacy for herself to mix and inject. “No thanks,” we wrote, hoping this sketchy business would […]

FDA is in a quandary about compounding of the new obesity drugs, semaglutide and tirzepatide. The U.S. President-Elect has a nominee to lead FDA with a connection to this compounding kerfuffle. Marty Makary is a surgeon and professor at the Johns Hopkins School of Medicine. He is also Chief Medical Officer for the telehealth company […]

FDA told a Federal judge yesterday that the agency isn’t yet sure whether there’s still a shortage of tirzepatide in the U.S. The agency needs more time to think about this. So for now, we have a stalemate on compounding of both semaglutide and tirzepatide. They are still on the FDA shortage list and compounders […]

Research presented at ObesityWeek 2024 shines a light on a blind spot in drug labeling for persons with obesity. No, we’re not talking about the latest buzzy drug for treating obesity. Rather, we are talking about a prime example of labeling for other drugs that people with obesity may need when they face a serious […]

On again, off again. With impressive nimbleness, the U.S. Food and Drug Administration reversed course on tirzepatide compounding in large-scale pharmacy facilities. On October 2, they told those facilities to knock it off. Late last week, the agency told them to carry on – for now. FDA was responding to a lawsuit filed by compounding […]