The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.

President Joe Biden is nominating former Food and Drug Administration commissioner Dr. Robert Califf to again lead the powerful regulatory agency.

The Food and Drug Administration has paved the way for children ages 5 to 11 to get Pfizer’s COVID-19 vaccine.

U.S. health regulators have authorized an extra dose of the Pfizer or Moderna COVID-19 vaccines in people with weakened immune systems to better protect them from the virus.

The acting head of the Food and Drug Administration is calling for a government investigation into highly unusual contacts between her agency’s drug reviewers and the maker of a controversial new Alzheimer’s drug.

Children ages 12 and older can now get COVID-19 vaccines in the U.S., offering parents and schools a chance to relax their pandemic precautions.

U.S. health regulators are pledging again to try to ban menthol cigarettes.

Since last year, the FDA has been investigating NDMA and other impurities in blood pressure and heart failure medicines known as angiotensin receptor blockers or ARBs. Numerous recalls have been launched as the FDA found "unacceptable levels" of nitrosamines in several of those common drugs containing valsartan. So far, NDMA has been found in ranitidine in low levels and we are not calling for consumers and patients to stop taking ranitidine at this time," he said. The FDA will share more information with the public and industry as we learn more throughout the investigation." Woodcock said the FDA is working with international regulators and industry partners to determine the source of the ranitidine impurity.