Novartis Scemblix® FDA approved in newly diagnosed CML, offering ...

Ad hoc announcement pursuant to Art. 53 LR Scemblix, a new first-line option for adults with CML, is first to show superior efficacy and favorable safety and tolerability profile in a Phase III ... Read More

Novartis Pharma AG: Novartis Scemblix FDA approved in newly diagnosed ...

Ad hoc announcement pursuant to Art. 53 LR Scemblix, a new first-line option for adults with CML, is first to show superior efficacy and favorable safety and tolerability profile in a Phase III trial ... Read More

FDA Grants Accelerated Approval to Novartis’ Scemblix for Newly ...

Accelerated approval is based on results of the ASC4FIRST Phase III trial, which demonstrated Scemblix's superior efficacy in achieving major molecular response compared to standard of care tyrosine ... Read More

Novartis Scemblix® FDA approved in newly diagnosed CML, offering ...

Scemblix, a new first-line option for adults with CML, is first to show superior efficacy and favorable safety and tolerability profile in a Phase III trial vs. all standard of care (SoC) therapies ... Read More

Novartis’ Scemblix granted FDA accelerated approval in newly ...

In line with the FDA’s accelerated approvals pathway, continued approval for Scemblix in the newly diagnosed indication may be contingent upon verification and description of clinical benefit from ... Read More

Novartis Scemblix® FDA approved in newly diagnosed CML, offering ...

The expanded indication in Ph+ CML-CP increases the population eligible for Scemblix by approximately four times, including newly diagnosed and previously treated adults. Newly diagnosed patients will ... Read More

Novartis says Scemblix FDA approved in newly diagnosed CML

Newly diagnosed patients will now have access to a treatment that has shown superior efficacy vs. all standard of care therapies and a favorable safety and tolerability profile,” the company stated. Read More