Standards & Regulation

Ophthalmology is quietly becoming gene therapy’s next big frontier. Here’s how the science, the patients, and the regulations are aligning.

Martin A. Makary and Vinay Prasad write that “rapid or instant reviews” could be possible at the FDA.

All 17 members removed from advisory panel, with RFJ Jr claiming it is “plagued with conflict of interest.”

Our latest news roundup reports on Novartis’ prostate cancer trial, Sandoz’ osteoporosis biosimilars, and more.

The IQVIA Institute’s latest report evaluates how well seven countries are prepared to support the complex infrastructure required for CAR T therapies

We speak with experts from Amgen and Henry Ford Health about the development and approval of Uplizna for IgG4-related disease.

From bird flu to COVID-19 vaccines to alleged corruption in journals, we look into recent moves from US Health Secretary RFK Jr.

Our latest news roundup reports on a new blow for Harvard, how Pfizer and Astellas’ Xtandi improves cancer survival, and more.

We ask a company about lessons learned from the GMP certification process.

A report attempts to unravel the many challenges that face business leaders. We discuss those inherent in the pharmaceutical industry.