Heather McKenzie

The FDA has greenlit Orca Bio’s allogeneic T cell–based immunotherapy to reduce graft-versus-host disease in patients being treated for blood cancers. Tregzi marks the first approval of a cell therapy using regulatory T cells, according to the biotech. Tregzi is also Orca’s first approved therapy, “validating the company’s high-precision platform and the potential of its pipeline,” the California-based company said in a Tuesday press release.

> Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart Amgen’s Tavneos continues to face serious challenges, with the FDA still pushing for its removal from the market. Early this year, the agency identified issues with an analysis from the drug’s original developer, ChemoCentryx, which Amgen acquired for $3.7 billion in August 2022 after the drug’s 2021 approval.

Momentum is mounting again in Huntington’s disease. Two weeks after the FDA cleared uniQure to apply for accelerated approval of its gene therapy, Skyhawk Therapeutics’ oral drug has shown early signs of motor and functional improvements in patients with the intractable neurodegenerative disease.