Recent Posts
News•Mar 1, 2026
Weekly Reads: Longevity Hype Vs. Cool Research, Losing Your Y, FDA Maelstrom
This week’s coverage juxtaposes longevity hype with emerging science, highlighting David Sinclair’s bold claim that aging could be reversed within 10‑20 years, a new Nature paper confirming adult hippocampal neurogenesis, and research showing men lose the Y chromosome as they age. At the same time, the FDA’s Center for Biologics Evaluation and Research is embroiled in internal power struggles between Commissioner Marty Makary and CBER chief Vinay Prasad, leading to erratic rare‑disease drug decisions. The agency also released draft guidance for bespoke gene‑therapy approvals, promising a flood of individualized treatments. Together, these developments illustrate the tension between visionary biotech promises and regulatory realities.
By The Niche
News•Feb 19, 2026
From Skin Biopsy to iPS Cell Proposals: Emails Involving George Church’s Personal Genome Project and Jeffrey Epstein
Recent court‑released Epstein files contain emails that link Harvard professor George Church’s Personal Genome Project to Jeffrey Epstein. The correspondence documents a skin‑biopsy taken from Epstein, proposals to generate induced pluripotent stem (iPS) cells, and even CRISPR editing ideas, with...
By The Niche
News•Feb 11, 2026
FDA OKs Risky, Pioneering OSK Rejuvenation Trial with Sinclair’s ER-100
The U.S. Food and Drug Administration has cleared an investigational new drug application for Life Biosciences' ER‑100, a viral gene‑therapy that delivers inducible Oct‑4, Sox‑2 and Klf‑4 (OSK) to the eye. The first‑in‑human trial will enroll a small cohort of...
By The Niche
News•Feb 4, 2026
Wyoming Stem Cell Bill Is Latest Risky, Anti-FDA State Legislation
Wyoming Senate introduced the Stem Cell Freedom Act, allowing clinical use of autologous mesenchymal stromal cells without FDA approval. The legislation shields physicians from disciplinary action if they recommend such therapies, provided they meet state‑defined standards. Critics argue the bill...
By The Niche
News•Feb 1, 2026
Weekly Reads: Human SCBEM Framework, Reporter Self-Injects Peptides, ASD, NAMs
A new two‑tier framework for human stem‑cell‑based embryo models (SCBEM) proposes a developmental ceiling of 56 days, sparking debate over its impact on clinical applications. The blog also highlights ethical concerns after a reporter injected wellness peptides on record, questioning...
By The Niche
News•Jan 28, 2026
In Support of the Roman Reed Spinal Cord Injury Research Act
The California legislature is poised to pass the Roman Reed Spinal Cord Injury Research Act, allocating $1 million annually for up to five years to revive the previously successful Roman’s Law. The original program funded $12.4 million in state grants, leveraged $82.4 million...
By The Niche
News•Jan 21, 2026
Stem Cells for Stroke Hype Awardee 10 Years Ago Now Tells a Cautionary Tale
A decade‑old, sensational headline claimed Stanford stem‑cell therapy helped a stroke patient walk, sparking false hope. The product, SB623, showed modest signals in an early open‑label study but failed to meet endpoints in a Phase 2b stroke trial, leading to its...
By The Niche
News•Jan 18, 2026
Weekly Reads: FDA Politics, Lineage Cell Update, Tuft Cells & Cancer, Neuron Mitochondrial Transfer, Dead Celeb Genomics
The blog spotlights a surge of political influence at the FDA, noting RFK Jr.'s role in reshaping policy and even removing a warning on dubious autism therapies. It highlights Lineage Cell’s receipt of a gene‑edited hypoimmune iPSC line from Factor Bioscience,...
By The Niche
News•Jan 11, 2026
Weekly Reads: Organoids ‘Pregnant’ with Human Embryos, Neuralink, Biotech Scorecard, Iffy Autism Tests
Researchers have successfully co‑cultured human embryos with endometrial organoids, creating a 3‑dimensional post‑implantation model that mimics early pregnancy. The study, published in Cell Stem Cell, shows embryos can organize with organoid tissue for several days, offering a new platform for...
By The Niche
News•Jan 7, 2026
2026 Predictions: Historic FDA Shift, Plausible Mechanisms, Bespoke Tx, RFK Jr., Biotechs, State AGs, Peptides, Embryos
The blog forecasts a historic regulatory shift in 2026, with the FDA likely approving Capricor’s deramiocel for Duchenne muscular dystrophy and at least two additional cell therapies based on limited data. New FDA buzzwords—plausible mechanisms, N=1 trials, bespoke therapies, and...
By The Niche
News•Jan 4, 2026
Weekly Reads: The Stem Cell Niche, Tongue Stem Cells, Autoimmune Diseases
The post highlights recent advances in stem cell niche research, focusing on bone‑marrow organoid models, niche‑preserving intestinal transplants, and the discovery of tripotent Lgr5+ stem cells in the posterior tongue that generate lingual, taste, and salivary lineages. It curates related...
By The Niche
News•Jan 2, 2026
Grading My 25 Stem Cell & Regenerative Medicine Predictions for 2025
The author graded 25 2025 predictions for stem cell and regenerative medicine, finding most were accurate despite some disappointing headlines. Key highlights include reduced FDA oversight paired with notable warnings in the perinatal space, a successful Mesoblast approval, and several...
By The Niche
News•Dec 30, 2025
Colossal Biosciences Wins 2025 The Screamers Award for Science Hype on Dire Wolf De-Extinction Claim
Colossal Biosciences was awarded the 2025 The Screamers Award for its overstated claim of de‑extincting the dire wolf. In reality the firm only introduced a handful of dire‑wolf‑related gene edits into existing gray wolves, leaving the animals genetically gray wolves....
By The Niche
News•Dec 29, 2025
Top 5 Stem Cell Good News Stories of 2025
The 2025 stem‑cell roundup highlights five breakthrough developments: Capricor’s deramiocel for Duchenne muscular dystrophy is on track for FDA approval by 2026; three independent Parkinson’s trials reported encouraging early efficacy; Vertex’s diabetes program saw participants achieve insulin‑free periods; a Mass Brigham...
By The Niche