On April 27, 2026, Intellia Therapeutics (“Intellia”) announced that it has begun a rolling submission of a biologics license application (BLA) to the FDA for lonvoguran ziclumeran (lonvo-z), an investigational therapy for...more
On Monday, the U.S. Food and Drug Administration (FDA) published draft guidance formalizing a “plausible mechanism” approval framework for individualized therapies, particularly genome editing and RNA-based products. Although...more
On January 22, 2026, the National Institutes of Health (NIH) issued NOT-OD-26-028, prohibiting the use of NIH funds for research involving human fetal tissue (HFT) obtained from elective abortions (the Notice)....more
On December 15, 2025, the European Commission (EC) announced a legislative package that includes a proposal for a regulation to establish measures to strengthen the European Union’s (EU) biotechnology and biomanufacturing...more
After a four-day trial, Iowa Attorney General (AG) Brenna Bird obtained a ruling and judgment against Omaha-based stem cell businesses and its owner/CEO for deceptively marketing “regenerative medicine” stem cell injections...more
FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene therapies (“CGTs”):...more
For autologous cell and gene therapies (CGTs), the collection of patients‘ cells is the first step in the manufacture of the medicinal product. In Germany, this step is usually conducted by specialized treatment centers that...more
On July 1, 2025, Florida’s new “Stem Cell Therapy” legislation became effective, adding Fla.Stat. § 458.3245 to Florida’s Medical Practices statutes and § 459.0127 to Florida’s Osteopathic Medicine statutes. Florida’s new...more
Since the year began, we have attempted to divine the new administration’s approach to regulating human cell and tissue products (“HCT/Ps”). What we have found is a collection of seemingly contradictory signals, keeping us...more
Key Takeaways - - The U.S. Food and Drug Administration (FDA) recently issued three draft guidances concerning development of cell and gene therapy (CGT) products. The guidances provide advice concerning qualifying CGTs...more
In late September, the U.S. Food & Drug Administration (“FDA”) issued three draft guidances related to cell and gene therapy (“CGT”) products: (1) Innovative Designs for Clinical Trials of CGT Products in Small Populations...more
The U.S. Food and Drug Administration (FDA) on Sept. 20, 2025, issued draft guidance, "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions," outlining how sponsors can utilize FDA's expedited review...more
On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to clinical trial design,...more
Japan continues to position itself as a global leader in regenerative medicine through its progressive regulatory framework tailored to the unique characteristics of cell, tissue, and gene therapy (CTGT) products....more
On September 27, 2024, the U.S. Court of Appeals for the Ninth Circuit reversed the district court’s decision in U.S. v. California Stem Cell Treatment Center, Inc. (“California Stem Cell”), holding that a clinic’s stem cell...more
Treatment and prevention of heart failure are unmet medical needs in the United States. One in every eight deaths in the United States can be linked to this disease. The Keck School of Medicine at USC and the biotechnology...more
On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from...more
A recent New York Times article reported that dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures. Burst...more
Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should be regulated as new drugs. The decision...more
Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products (HCT/Ps) will be required to file a biologics license application (BLA) with...more
Last month, the Centers for Medicare & Medicaid Services (CMS) released new and significant proposals impacting Medicare coding, coverage, and reimbursement for a class of regenerative medicines known as “skin substitutes,” a...more
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...more
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein, and Thomas Beimers discussed evolving government reimbursement issues for...more
On June 29-30, 2022, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) to discuss its regulatory expectations for...more
On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace period intended to provide developers of human...more