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 ...

Novartis has received US Food and Drug Administration (FDA) accelerated approval for Scemblix (asciminib) to treat adults ...

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.