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

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

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.

Johnson & Johnson JNJ announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its ...

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...

Scientists at UCSF and Gladstone Institutes have identified cancer drugs that promise to reverse the changes that occur in ...

The standard threshold for approval in an FDA clinical trial is a false positive rate of 2.5 percent or less; in other words, the FDA is willing to tolerate approving ineffective drugs 2.5 percent ...

Drugs that treat serious or life-threatening conditions and fulfill unmet medical needs are eligible for review by the FDA under the accelerated approval pathway. 1 This pathway is “accelerated ...

The legislation was spurred by the fracas over the Alzheimer’s drug Aduhelm, which received a so-called accelerated approval. Nearly every member of an FDA advisory panel voted against approving ...

While we all value the fact that the FDA goes to great lengths to ensure the safety and efficacy of new drugs, the process can often drag on for over a decade, depriving people of live-saving drugs.

How FDA approval will change COVID-19 ... In its review for approval, the U.S. Food and Drug Administration analyzed clinical trial data from about 20,000 vaccine recipients and concluded ...