The U.S. Food and Drug Administration has appointed George Francis Tidmarsh, M.D., Ph.D., as director of the Center for Drug Evaluation and Research (CDER).

The FDA is taking steps to ban current prescriptions.

D r. James H. Bekker made it clear while standing at a podium in front of the U.S. Food and Drug Administration (FDA) in ...

Analysts downgraded Sarepta as FDA pause on Elevidys raises regulatory uncertainty, leading to significant stock pressure and valuation cuts.

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 ...