Posts Tagged ‘FDA’

Recent news from Hims & Hers adds to our discomforting thought that compounded GLP-1s have become little more than a ploy to grab quick money from vulnerable consumers. Thursday, the company announced they are launching a compounded semaglutide tablet to compete with Wegovy. Reporting from Reuters suggests this announcement aimed to spark gains in their […]

Usually, when new medicines have been on the market for a time, warnings tend to accumulate in the prescription labeling. So it is a bit unusual to see the FDA move to remove a warning. But recently, that’s exactly what happened with semaglutide and tirzepatide. FDA is making a course correction on warnings about suicidal […]

We strongly suspect that advanced oral obesity medicines may be a defining milestone for 2026. This is because they have the potential to fill an important gap in obesity therapy – the unmet need for therapies that people can persistently take to maintain control of this chronic disease. Late yesterday, FDA granted approval for the […]

President Trump held a press event yesterday to issue some very welcome news on coverage and prices for obesity medicines. On prices, they are coming down. In reality, this is an extension of the ongoing trend of downward pressure on these prices that has been in play since the day that semaglutide and tirzepatide launched […]

FDA and the MAHA Commission seem to be making health labels for food and beverage products a priority. But it looks like the front-of-pack label in the current proposal is relatively ineffective. At least that’s what we’re seeing in a new randomized controlled study by Anna Grummon et al in JAMA Network Open. It was […]

The short supply, high prices, and despicable insurance restrictions for advanced obesity medicines have created many problems. For example, compounding of these medicines has been and continues to be controversial – for good reasons. Now, FDA is recognizing one of the most pernicious threats to emerge from this situation – sketchy sellers of “research” peptides. […]

Last week, in a meeting with senior staff from the FDA responsible for labeling, we were dumbfounded. We learned that these pharmacologists did not regard it as important for clinicians to know the half-life of posaconazole in persons with obesity. In fact, they told us “it could potentially be confusing.” On the spot this was […]

Yes, wearable tech for personal health and fitness monitoring is still with us, but it comes in waves. The first wave, with Fitbit, peaked sometime around 2017, judging from Google search interest. The second wave came with smartwatches. The Apple Watch launched in 2015 and interest in smartwatches peaked in 2020. Now the hot new […]

Late yesterday FDA granted Wegovy (semaglutide 2.4 mg) a big new indication – treatment of MASH. The indication FDA approved reads as follows: “For the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults. “The indication […]

A new physiologically based pharmacokinetic (PBPK) study demonstrates that the elimination half-life of posaconazole is significantly prolonged in individuals with obesity – especially those with a BMI ≥ 35 kg/m² – compared to people with normal weight. The labeled half-life for posaconazole is typically 26–35 hours. But in persons with obesity, this can extend to nearly 58 […]