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

US regulators rejected a skin cancer treatment from Replimune Group Inc. in another sign of the agency’s new leadership ...

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.

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

The FDA approved a label update with a new titration schedule for donanemab (Kisunla), an anti-amyloid drug approved to treat ...

Researchers say that a pair of already FDA-approved medications could reverse brain changes in the most common form of ...

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

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 ...

The FDA has not yet withdrawn the drug's approval, ... Changes to the accelerated approval process ultimately passed in the year-end omnibus spending bill that was signed into law on Dec. 29.

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to ...

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 ...

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 ...