Katherine Szarama, PhD, named Acting CBER Director: who’s next?

by rss feed | May 1, 2026 | CBER, FDA, Katherine Szarama, News Feeds

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...

Weekly reads: Prasad successor, Sammy Hagar stem cells, more on OSK trial, Finnish speaker needed

by rss feed | Apr 19, 2026 | FDA, News Feeds, Vinay Prasad, weekly reads

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...

Weekly reads: Prasad exit & replacement, FDA on Leucovorin, Mexico’s stem cell clinic industry

by rss feed | Mar 15, 2026 | FDA, News Feeds, Prasad exit, weekly reads

Vinay Prasad, the outgoing CBER Director (right), with Commissioner Marty Makary, at a cell and gene therapy roundtable last year. Vinay Prasad is leaving the FDA again in a few weeks. As CBER Director, Prasad was all over the place on how he handled oversight of...

GOP lawmakers ask RFK Jr. to make FDA unleash risky peptides like BPC-157

by rss feed | Dec 18, 2025 | FDA, FDA enforcement discretion, News Feeds, peptide risks, Peptides, RFK peptides

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...

Gamida Cell’s Omisirge for SAA gets OK on limited data; more low-data FDA approvals likely to come

by rss feed | Dec 10, 2025 | FDA, Gamida Cell, News Feeds, Osimirge, Severe Aplastic Anemia

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...

Weekly reads: WSJ vs. Prasad, MUSE cells, Lyme disease, longevity signal vs. noise

by rss feed | Sep 28, 2025 | FDA, News Feeds, Vinay Prasad, weekly reads

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...