Marty Makary Departs the FDA, healthcare attorney Kyle Diamantas to replace him
FDA Commissioner Marty Makary resigned on 12 May 2026, after roughly 14 months leading the agency, with Kyle Diamantas set to replace him. Makary’s tenure was marked by significant debate surrounding regulatory oversight, drug approvals and the FDA’s broader direction under increasing political scrutiny. President Trump confirmed that Kyle Diamantas, the FDA's Deputy Commissioner for Food and head of the Human Foods Program, will serve as acting commissioner while a permanent replacement is sought. For the cell and gene therapy sector in particular, which has already experienced significant friction under Makary's tenure, the transition raises urgent questions. Diamantas brings a legal and policy background with strong ties to HHS and the White House, rather than a scientific or clinical one, which may shift the tone of engagement between industry and the agency.
Read more via First World Pharma and The Guardian
Fractyl Health’s GLP-1 Gene Therapy Becomes First to Enter the Clinic
Fractyl Health has received Clinical Trial Application authorisation from European regulators in the Netherlands to proceed with a first-in-human Phase I/II study of RJVA-001, making it what the company believes is the world's first adeno-associated virus (AAV)-based gene therapy candidate to enter clinical development for type 2 diabetes. The therapy targets beta cells within the pancreas, seeking to restore or augment natural GLP-1 signalling in a potentially durable, one-time intervention. This trial represents a convergence of two transformative forces in modern medicine: the GLP-1 revolution and gene therapy. The GLP-1 drug market has seen explosive growth, but current therapies require ongoing, often costly injections, and patient adherence remains a significant challenge. A one-time gene therapy approach could fundamentally disrupt the commercial landscape for both GLP-1 manufacturers and the broader metabolic disease market.
Read more via Endpoints News and Clinical Trials Arena
MHRA Opens Consultation to Modernise the Definition of Gene Therapies
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a UK-wide consultation proposing updates to how gene therapies are formally defined and classified. The current definitions were established more than a decade ago and have not kept pace with rapid advances in gene editing, synthetic biology, and novel delivery technologies. The consultation identifies five key proposals: removing the requirement for gene therapies to be biological in origin; clarifying when synthetic or recombinant nucleic acids bring a product into regulatory scope; ensuring sequence-specific genome editing technologies are clearly regulated as GTMPs; maintaining the existing exclusion of vaccines against infectious diseases; and updating the Human Medicines Regulations 2012 accordingly. Crucially, the MHRA has emphasised that the proposed changes will not alter the existing approval process, the regulatory status of licensed products, or safety and efficacy standards.
Read more via GOV UK and National Health Executive
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