The US is hooked on unregulated peptides. But are they effective, or even safe?
livescience - The world of peptides has exploded in wellness circles, but the benefits of injecting these gray-market molecules rest on little clinical evidence.
AI Summary: Unregulated peptide products have proliferated in the US, raising safety and efficacy concerns as federal regulators convene a contentious panel that includes proponents of these off‑label compounds. The debate highlights a market gap where hype often outpaces evidence — and where regulators must decide whether to tidy up the wild west or watch it fester.
Orca Bio Cell Therapy Gets Landmark FDA Nod for New Kind of Living Medicine
Frank Vinluan / medcitynews - FDA approval of Orca Bio’s Tregzi makes it the first cell therapy based on regulatory T cells, or Tregs. Clinical trial results showed reduced risk of graft-versus-host disease, a common complication of the allogeneic stem cell transplants that are a stan…
AI Summary: Orca Bio’s off‑the‑shelf allogeneic cell therapy received FDA approval, marking a milestone for engineered living medicines. Regulators cleared the product after pivotal efficacy and manufacturing data, offering broader access to cellular therapy but spotlighting cost, supply logistics and the need for robust post‑market safety surveillance.