The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy ...

The new accelerated approval covers the use of Scemblix for newly diagnosed patients with Philadelphia chromosome-positive ...

But the FDA approval never came, and the press release was never officially distributed. Eight months later, the FDA still hasn't approved the Snoo as a medical device, according to public records.