Agency eyes have zeroed in on oncology, with the FDA Oncology Center of Excellence (OCE) introducing frameworks such as ...

The initiative, Project Optimus, launched in 2021 just as Amgen was seeking to market sotorasib. At the time, the FDA’s leading cancer drug regulator, Richard Pazdur, co-wrote an editorial in ...

The FDA has proposed that this historical approach is inadequate and have setup a new initiative termed Project Optimus to highlight the importance of characterising the dose and schedule. A key goal ...

The FDA Oncology Center of Excellence introduced Project Optimus with goals that included communications of expectations, opportunities for direct discussions between the FDA and sponsors, and the ...

The US Food and Drug Administration’s (FDA) Oncology Center of Excellence officially announced its Project Optimus initiative draft guidance in January 2023, and pharmaceutical and biotechnology ...

The Oncology Center of Excellence initiative, Project Optimusa, and its related FDA Draft Guidance emphasize the shift from ... An overview of important aspects of Project Optimus and accelerated ...

For decades drugmakers have taken a more-is-more model when dosing cancer drugs in clinical trials. U.S. regulators want them to reconsider that approach. Companies with cancer drugs in clinical ...

The origin story of Optimus Prime and Megatron is nothing short of sensory overload and not a whole lot else, writes our ...