Posts Tagged ‘FDA’
November 7, 2025 — 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 […]
October 19, 2025 — 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 […]
September 6, 2025 — 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. […]
September 4, 2025 — 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 […]
August 21, 2025 — 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 […]
August 16, 2025 — 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 […]
August 1, 2025 — 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 […]
July 30, 2025 — Monday, Reuters reported that Novo Nordisk has been seeing a bump in prescription volume for Wegovy because FDA had ordered an end to the widespread sale of compounded semaglutide on May 22. New Wegovy prescriptions were up 33%, the report said. But they went on to say that investors were looking for more assurance of […]
July 11, 2025 — A new scientific statement from the American College of Cardiology (ACC) marks a milestone in acknowledging the importance of treating obesity in patients with heart failure. It seems that cardiologists see the light and are recognizing the importance of moving beyond diet and lifestyle advice alone. The statement concludes: “Given emerging evidence of the benefits […]
July 7, 2025 — FDA Commissioner Marty Makary believes that defining ultra-processed foods is the key to overcoming the health problems these products produce. He recently told the New York Times: “We do not see ultra-processed foods as foods to be banned. We see them as foods to be defined so that markets can compete based on health.” So […]