One of the questions I get asked most often about pop peptides is why they are so popular. What puts the “pop” in pop peptides? Peptide mania After all, these peptides like Ipamorelin, BPC-157, and so on don’t have clinical trial data to support the uses for which they are being marketed. That makes them […]
The FDA & compounding pharmacy telehealth connections on pop peptides Read More »
I’ve been thinking more about the interplay between patient voices and FDA oversight of emerging cell and gene therapies. How do we find integration and balance here? In line with this topic, the FDA’s Megha Kaushal, MD spoke last week in Boston at ASGCT 2026 on patient voices. Kaushal is the Acting Deputy Director, Office
FDA’s Megha Kaushal ASGCT talk: PFDD, patient voices, decision-making Read More »
Have we reached the reproductive frontier of lab-grown sperm? Producing oocytes in the lab has always been thought to be the initial focus in this arena. It was thought that figuring out the way to maked lab-grown sperm would take longer. Now a new report suggests both sperm and eggs can be made by in
Yesterday was Vinay Prasad’s last day as the Director of CBER, the FDA’s biologics branch and as of today Katherine Szarama is Acting Director. Is there some significance to Szarama being acting director? It’s hard to say. Most signs seem to suggest someone else will become the permanent leader. Katherine Szarama background From Politico: “Szarama
Katherine Szarama, PhD, named Acting CBER Director: who’s next? Read More »
Vinay Prasad has only less than two weeks left at the FDA atop CBER. I’ve been trying to imagine where CBER goes from here after he exits. It feels like FDA Commissioner Marty Makary and RFK Jr. will likely be the real leaders of CBER moving forward on key decisions. Under that pressure, will the
RFK Jr. posted last year about wanting to weaken FDA oversight of both stem cells and peptides. What we mean by peptides here is a class of unproven and non-FDA-approved drugs sold by wellness influencers. Compounding pharmacies have made such wellness peptides available in the past before the FDA rightly became more restrictive about their
GOP lawmakers ask RFK Jr. to make FDA unleash risky peptides like BPC-157 Read More »
The FDA just announced it approved the cell therapy Omisirge from Gamida Cell for severe aplastic anemia (SAA). This is the first cell therapy approved for SAA. SAA is a rare, life-threatening blood disorder. It is often treated with hematopoietic stem cell transplants or immunosuppression. There’s a major autoimmune component to the condition. The FDA
The conservative Wall Street Journal continues to go after FDA CBER Director Vinay Prasad. WSJ still doesn’t like CBER Director Vinay Prasad What’s going on? Here’s a new piece from the paper’s editorial board: Dr. Prasad, the FDA’s Grim Reaper. That’s a strong headline. The piece is also critical of RFK Jr. Earlier Prasad temporarily
Weekly reads: WSJ vs. Prasad, MUSE cells, Lyme disease, longevity signal vs. noise Read More »
Vinay Prasad is out at the FDA after less than three months. It may be the shortest tenure as CBER Director in FDA history. This is an ominous sign for the agency, but probably not just for the reasons you might first think. Vinay Prasad’s departure and gaps in FDA leadership Prasad had three key roles.
Why sudden Vinay Prasad departure from FDA is about more than Sarepta missteps Read More »
Marty Makary’s FDA appears to be struggling on several fronts. It’s not surprising but comes with big risks for the agency and country. Think of the departures of Peter Marks, Nicole Verdun, Celia Witten, and many others like staff scientists, physicians, and attorneys. Huge numbers of key support staff, who help make the wheels turn
Is Makary’s FDA already heading toward a breaking point? Read More »