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

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

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

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

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

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

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

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.

Stay informed on key pharmaceutical news, including tariff updates, FDA shutdown risks, and insights from recent cell and ...

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

President Trump is using the threat of 100% tariffs on pharma imports as a negotiation tactic to lower drug prices. Pfizer ...