Posts Tagged ‘FDA’

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 […]

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 […]

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 […]

“If HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary want to bring radical transparency to U.S. healthcare, they can start by updating drug labels that lack good information for persons with larger bodies. ” In RealClearHealth yesterday, an editorial by Caroline Apovian and Ted Kyle called for policymakers at FDA to deliver […]

The game is over. Today is the day legal semaglutide compounding at scale ends by decree from the FDA. Compounding pharmacies have known this day was coming since February when the agency determined that the shortage of semaglutide from Novo Nordisk was over. Well-informed patients who have depended upon compounding for affordable access to a […]

Rather quietly this week, Eli Lilly and Company announced that it had withdrawn an application to FDA for an indication to use tirzepatide (Zepbound) in treating heart failure – specifically for HFpEF. This news came up in a briefing for investors, with Lilly’s Chief Scientific Officer, Dan Skovronsky, saying: “Following discussions with the FDA, we’ve […]

Change is hard and people resist it. FDA is coming to terms with the idea of radical transparency and certainly drug labels are a good place to start. When we talk about drug labels for prescription drugs, it means the lengthy “prescribing information” that FDA reviews and approves. Its purpose is to tell doctors, pharmacists, […]

On Tuesday, as part of mass firings, the powers that be at FDA lined people up to fire them. Security guards delivered the news. Clumsily. Now, just two days later, it seems they want a do over. The Washington Post reports the agency is trying to bring back a big chunk of people they fired: […]

Yesterday was a profoundly sad day for people who care about American greatness in health. With a measure of gratuitous cruelty, the U.S. Department of Health and Human Services slashed 10,000 jobs, wiping out a stunning breadth of health expertise at FDA, CDC, and NIH. Robert Califf, an international expert in clinical research and cardiovascular […]

In the U.S., we are at a critical point for the sourcing obesity medicines. March 19 was the last day that FDA would tolerate large scale compounding of tirzepatide on account of the now resolved shortage of that drug. The same milestone for semaglutide is coming up on May 22. Some people are not happy. […]