In today’s Pharmaceutical Executive Daily, we cover the FDA’s new fast-track review program for U.S.-made generics, Novartis’ ...

In August, the agency announced a new program called FDA PreCheck, 2 which is designed to increase regulatory predictability ...

Roche's Tecentriq and lurbinectedin combo gains FDA approval, significantly improving outcomes for extensive-stage small cell ...

Jazz Pharmaceuticals announces FDA approval of Zepzelca and Atezolizumab for extensive-stage small cell lung cancer, ...

Though exciting and rapidly advancing, the success of future AI systems will continue to rely on trust and clinical alignment. To be adopted at scale, medical AI must integrate seamlessly into ...

Jason O’Neill, author of 'The Secrets of Successful Drug Launches' and former Dendreon CEO, covers the five stages of the innovation process and how they can be used to improve operations.

Kitamura discusses implementing cost management initiatives and positioning the company to weather near-term challenges.

Takeda shifts focus from cell therapy to innovative drug candidates, aiming for transformative therapies and strategic ...

Gen Li, founder and president of Phesi, discusses how the rise of GLP-1 medications is impacting how various diseases are ...

Vanda Pharmaceuticals collaborates with the FDA to expedite reviews for Hetlioz and Tradipitant, aiming to resolve ongoing ...

FDA continues essential operations during the funding lapse, focusing on public health safety while halting new drug ...