I sat in on the AI session at ARM’s Cell & Gene Meeting on the Mesa this week, and Steven Oh, Director, Office of Cellular Therapy and Human Tissue, US FDA, said something that stuck with me: “AI has a lot of promise, but there are a lot of challenges ahead.” He also spoke to […]
On Monday morning at the Arizona Biltmore in Phoenix, Karim Mikhail opened the Alliance for Regenerative Medicine’s 2026 Cell & Gene Meeting on the Mesa. Mikhail became the permanent Director of FDA’s Center for Biologics Evaluation and Research in September. CBER leadership has turned over a lot this year, so the room was listening closely […]
With the official August 2026 numbers reported, let’s take a walk on the wild side and try to predict what the full FY 2026 ANDA approval numbers may look like as we won’t see the full FY 2026 official report on approved ANDAs until sometime in November. Data from the FY 2026 Generic Drugs Program […]
The FDA is asking for comments on how the early-phase clinical trials initial study of ibogaine for the treatment of opioid use disorder and post-traumatic stress disorder (PTSD) can be carried out safely. The issue is centered on ibogaine’s association with potentially serious QTc interval prolongation and potential life-threatening Torsades de pointes (TdP) syndrome. The […]
On October 1, 2026, the “FDA approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease”. What makes this implantable heart valve device so special is that it can be adjusted in size as the child grows and, as a result, potentially eliminates the need for […]
During Dr. Heidi Overton’s confirmation hearings, she did not answer all of the questions directly asked of her, like would she bend to the President if she strongly disagreed with his position based on medical grounds. There were also questions regarding the abortion pill and vaccines where her answers took (what one might call) a […]
While not yet available in pharmacies, Onswik (insulin efsitora alfa-gobe) injection for subcutaneous use was approved by FDA on September 23, 2026. So, what’s new? This is a once weekly injectable insulin (instructed to be injected on the same day of the week), which according to the Lilly webpage here (and also by my own […]
In our global industry, the FDA does not want to fall behind countries like China and Australia where first in human studies have an expedited pathway. Operation Trialblazer is designed in part to do that for US companies. It is described by HHS and FDA as an “initiative to modernize and accelerate clinical drug development […]
CDER published a study titled “First-Cycle Complete Response Rates for CDER NDA and BLA Applications” (here). I read and reread it a few times and I am still confused. It appears that FDA published this report to counter industry’s stated belief that the number of Complete Response Letters (CR) have increased over time. This is […]
Just like the new season of Slow Horses premiering in September on Apple TV, it appears that September is also starting out to be a “slow” approvals action month at OGD. With this being midway through the last month of FY 2026, thus far through September 15th, OGD posted only 17 full approval actions and […]
