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

Scientists are seeing signals that COVID-19′s alarming omicron wave may have peaked in Britain and is about to do the same in the U.S., at which point cases may start dropping off dramatically.

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.

The U.S. has moved a step closer to offering booster doses of Pfizer’s COVID-19 vaccine to seniors and others at high risk from the virus.

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.

Montana Gov. Greg Gianforte has issued an executive order banning the development or use of vaccine passports in Montana.

-- Maryland will reduce indoor operations for bars and restaurants from 75% to 50% in response to rising coronavirus cases and increased hospitalizations. Maryland also reported 1,338 new coronavirus cases Tuesday — the seventh straight day of at least 1,000 cases. ___WASHINGTON — The U.S. has surpassed 1 million new confirmed coronavirus cases since the start of November. The El Paso County sheriff’s office says two of the employees were hospitalized over the weekend as coronavirus cases surged at the facility. Officials first reported the outbreak on Oct. 26 when eight inmates tested positive for COVID-19.

“The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms,” said Janet Woodcock, director of the Center for Drug Evaluation and Research. According to WFTV, The Food and Drug Administration announced Wednesday it was aware metformin in other countries contained low levels of NDMA, but those levels were in the “naturally occurring in food and water” range. NDMA is a common contaminant found in water and foods including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of NDMA, Woodcock said. The FDA recommends patients continue taking metformin to keep their diabetes under control because “there are no alternative medications that treat this condition in the same way.”

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.