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FDA questions on generative AI-enabled chatbots raise concerns from expert panel

During the second meeting of the US Food and Drug Administration’s (FDA) Digital Health Advisory Committee (DHAC), members of the panel seemed shocked and, at times, lost for words when grappling with the Agency’s discussion questions surrounding the potential regulation of generative Artificial intelligence (AI)-enabled digital mental health medical.

There are more than 100 autoimmune diseases, and they mostly strike women.  Here is what to know.

Autoimmune diseases are numerous, affect mostly women: There are more than 100 autoimmune diseases that collectively affect tens of millions of people, predominantly women, and diagnosing autoimmune diseases can be challenging due to vague and overlapping symptoms that mimic other illnesses. Multiple tests, including blood tests for specific antibodies, are often required. New research is focusing on reprogramming the immune system to cure autoimmune diseases.

Single antivenom protects against 17 different snakebites:  Researchers immunized an alpaca and a llama with snake venoms, and combined some of the antibodies produced into a potent cocktail.

Llamas, alpacas source of broad-spectrum snake antivenom: Scientists working with llamas and alpacas have created a new antivenom that neutralizes venom from 17 species of deadly African snakes by combining eight (8) nanobodies derived from the animals’ immune responses. When tested with mice, the cocktail protected against multiple venoms and reduced tissue damage, suggesting a new path toward safer and broader antivenom treatments for humans.

First clinical trial of pig kidney transplants gets underway

Trial of transplanted pig kidneys begins: The first clinical trial of pig kidney transplants is underway, with United Therapeutics announcing a successful initial procedure at NYU Langone Health. The trial, which may expand to 50 participants, will follow recipients of gene-edited pig kidneys. Genes that may trigger rejection are knocked out, and some human genes that promote compatibility are added.

Senate Votes Down Two Healthcare Bills

The Senate has rejected bipartisan ACA subsidy bills as millions face doubled premiums when financial assistance expires at the end of 2025.

‘Major Gap’ in Many Randomized Controlled Trials of Major Depressive Disorder

Many depression trials exclude real-world patients, study finds: A new analysis presented at the 2025 European College of Neuropsychopharmacology Congress found that about one-third (1/3) of people with major depressive disorder would not qualify for most randomized controlled trials of antidepressants, revealing a major gap between research and real-world patients. Common exclusion factors included substance use disorder, prior suicide attempts, comorbid serious somatic disease and other psychiatric disorders.

FDA Clears First Blood Test for Alzheimer’s Disease:  A new blood test simplifies Alzheimer’s detection, offering a reliable and less invasive alternative to PET scans and spinal taps.

FDA cleared Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio for marketing. The test measures two proteins in a blood sample to measure amyloid plaques associated with Alzheimer’s. The results are highly reliable but must be interpreted in conjunction with other patient clinical information.

Poisonous sacs helped toads conquer the world

Iconic amphibians took an unexpected path across the globe, study finds — with toxins as a “game changer”. The Asian common toad, which was accidentally introduced to Madagascar by humans, secretes deadly toxins from specialized glands behind its eyes.