While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug ...

George Tidmarsh appointed to lead FDA drug review division amid staffing cuts and scrutiny over accelerated approvals and ...

The FDA has named Dr. George Tidmarsh to lead its drug division, putting him at the helm of the agency’s drug approval ...

Roche AG’s Genentech unit disclosed outcomes of two studies testing IL-33-targeting astegolimab vs. placebo on top of standard-of-care maintenance therapy in subjects with moderate to very severe ...

A House subcommittee will hold a hearing today covering safety lapses and improvements to be made to the organ donor system. In other news: the FDA's debate on antidepressant use during pregnancy; the ...

George Tidmarsh is a millionaire co-founder of a biotech firm, serial entrepreneur, neonatologist and adjunct professor at ...

The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency's drug program, the latest in a string of leadership changes at the agency.

Astronomer's new CEO is speaking out about the Coldplay concert kiss cam controversy, admitting the viral video has raised ...

Ticker: Americans putting money in investment income; FDA names former pharmaceutical company executive to oversee US drug ...

“Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development — ...