Study harnesses a cell-type-specific, multi-target drug discovery strategy grounded in human data and real-world evidence.

Alzheimer’s disease remains one of medicine’s toughest challenges, affecting millions and costing trillions of dollars ...

The Supreme Court’s recent unanimous decision on FDA’s drug-approval authority is utterly unremarkable.

An analysis from the Congressional Budget Office warns that cuts to the National Institutes of Health and FDA drug reviews could significantly reduce the number of new medications reaching the U.S.

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

The U.S. government is nixing a whole slew of "obsolete" U.S. food standards that Trump administration officials say also ...

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and ...

A former critic of FDA and Pharma will now oversee the regulation of costly and complicated biologics like vaccines, gene therapies, and blood supply.

Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing ...

The FDA created the accelerated-approval pathway in 1992, largely in response to the HIV–AIDS crisis, to get urgently needed drugs to the market without delay.

Federal drug officials on Monday announced the full approval of the Pfizer vaccine against COVID-19, a long-awaited step that will give employers a stronger legal foundation to impose vaccine ...

How The FDA Could Change The Way It Approves Drugs By Andrew Flowers Filed under Findings Illustration by Tomi Um ...