Quick perspectives on Karim Mikhail as new permanent CBER director

by rss feed | Sep 9, 2026 | CBER Director, FDA, News Feeds

Karim Mikhail, acting CBER director, has just been named the permanent branch leader. What might this mean for the cell and gene therapy field? Karim Mikhail is permanent CBER director, unusual background Most people in the field want more stability and logic-based...

Key FDA victory on stem cell clinics: permanent injunction against Cell Surgical Network, et al.

by rss feed | Aug 28, 2026 | Cell Surgical Network, FDA, News Feeds

After many years bouncing around the courts, today the FDA finally prevailed in getting a permanent injunction against a chain of stem cell clinics, Cell Surgical Network, and its flagship clinic California Stem Cell Treatment Center as well as its remaining leader,...

Weekly reads: more FDA flexibility on rare diseases, elephant iPS cells, heritable human CRISPR, RTT rarely used, digit regeneration

by rss feed | Jun 28, 2026 | elephant stem cells, FDA, News Feeds, weekly reads

The last eighteen months have been an unprecedented time of unpredictability for the FDA, but moving forward we’re likely going to see an emerging consistency: a higher amount of FDA flexibility on rare diseases. It’s already begun and is likely to...

The FDA & compounding pharmacy telehealth connections on pop peptides

by rss feed | Jun 10, 2026 | FDA, News Feeds, Peptides, telehealth peptides

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...

FDA’s Megha Kaushal talk: PFDD, patient voices, decision-making

by rss feed | May 20, 2026 | ASGCT 2026, FDA, FDA patient voices, Meetings, Megha Kaushal, News Feeds, PFDD

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...

Weekly reads: lab-grown sperm, stem cell pills, intranasal EVs, EMF Cell paper doubts, Makary toast?

by rss feed | May 10, 2026 | FDA, IVG, News Feeds, stem cell IVF, weekly reads

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...