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One Research Firm Puts Regenerative Medicine at $41 Billion, Heading for $162 Billion. Dr. David Borenstein on Why the FDA Keeps Cracking Down on Unproven Clinics.

DelveInsight, a market-research firm, estimates the global regenerative medicine market at about $41 billion in 2025 and projects roughly $162 billion by 2034. The FDA has spent years pursuing clinics selling unapproved stem cell products, most recently in a January 2025 warning letter to a Pompano Beach, Florida manufacturer. Dr. David Borenstein, a physician who offers regenerative treatments, says patients should ask what a product is before they book.

By Thomas Gutierrez · October 15, 2026

Explainer

The FDA Approved It. Whether You Can Get It Depends on a Different Document.

Updated 2026-27 COVID vaccines from Pfizer/BioNTech, Moderna and Novavax have FDA approval and target the circulating XFG variant. Eligibility guidance has narrowed to those 65 and over and younger adults with qualifying conditions. Insurers say they intend to cover. Three different documents, and only one of them is the one a pharmacy reads.

By Thomas Gutierrez · September 8, 2026

Health

The Trial Showed It Was Not Worse. The Label Now Says It Cuts Risk.

The FDA has approved tirzepatide to reduce major cardiovascular events in adults with type 2 diabetes. The trial behind it compared the drug not with placebo but with dulaglutide, an older GLP-1 that already had the indication — and the result was non-inferiority, with an 8 percent lower event rate.

By Thomas Gutierrez · September 4, 2026

The Long View

One Plant, One Drug, and a Regulator Choosing Which Failure the Patient Gets

Ifosfamide has been in critical shortage for about three months. It is a decades-old chemotherapy used in curative and salvage regimens for sarcoma and testicular cancer, and American supply ran overwhelmingly through one contract plant in Germany, which the FDA had cited in March for recurrent microbial contamination.

By Thomas Gutierrez · September 3, 2026