FDA Halts New Drug Submissions Amid Shutdown
Summary:
Due to the U.S. government shutdown, the FDA has paused acceptance of new drug and device applications. About 86% of staff will continue reviewing existing submissions funded by user fees, but most other regulatory work – like food safety and oversight of compounded drugs – will be suspended. Analysts say a short shutdown may cause little disruption, but a prolonged one could delay research, insurance talks, and new medical product approvals.
Nobel Prize Honors Discoverers of Immune System’s “Brake”
Summary:
The 2025 Nobel Prize in Physiology or Medicine was awarded to Mary Brunkow, Fred Ramsdell, and Shimon Sakaguchi for uncovering regulatory T cells – immune cells that prevent the body from attacking itself. Their discovery revealed how the immune system maintains balance, paving the way for therapies targeting autoimmune diseases such as type 1 diabetes, lupus, and arthritis. Sakaguchi first identified regulatory T cells in 1995, while Brunkow and Ramsdell later linked the Foxp3 gene to their function. The findings have since inspired over 200 clinical trials exploring new treatments to restore immune tolerance and reduce transplant rejection.
Breakthrough in Modeling Stress-induced Hair Greying Using Human Organoids
Summary:
At the 2025 IFSCC Congress in Cannes, Kyung Seo-yeon, Senior Researcher at Cosmax BTI, received the Basic Research Award for her study titled “Stress-Induced Hair Greying Modeled Using Human Hair-Bearing Organoids: A Step Toward a Sustainable Future.” The research introduced a human hair-bearing organoid model to investigate how stress influences hair pigmentation. According to reports, the model enabled in vitro observation of greying-related changes, demonstrating how human-derived systems can be applied to study complex biological responses in cosmetics research. This recognition reflects a growing shift toward human-based and ethical testing models that improve biological relevance while reducing reliance on animal studies.
Arthrosi Raises $153M to Advance Next-Generation Gout Drug
Summary:
San Diego – based Arthrosi Therapeutics has raised $153 million in Series E funding to advance its experimental gout treatment, AR882, a highly selective URAT1 inhibitor designed to better control uric acid levels with fewer side effects. The drug has completed mid-stage trials, and two Phase 3 studies are now fully enrolled, with results expected in 2026. Arthrosi joins several biotech companies pursuing improved URAT1-targeting therapies to offer safer, more effective alternatives to current gout treatments.
Scientists Create Human Eggs from Skin Cells
Summary:
Researchers at Oregon Health & Science University have turned human skin cells into fertilizable eggs – a breakthrough that could one day help treat infertility. Published in Nature Communications, the study showed that reprogrammed eggs could develop into early embryos, though none were genetically normal. The proof-of-concept suggests a future where people without viable eggs, including older women or same-sex couples, might have genetically related children. Experts say clinical use remains at least a decade away.
