Food and Drug Administration

Moderna Inc.’s Covid-19 vaccine was effective at preventing symptomatic disease in children ages 6 months through 5 years, Food and Drug Administration staff said in a review of the evidence.The FDA staff also said Friday that Moderna’s vaccine was generally safe in children in studies, including those under 5 years who haven’t had access to any shots. The assessment of the vaccine, part of the FDA’s standard process for deciding whether to permit use of a medicine, might bode well for the…

A federal program that has sped hundreds of new drugs to cancer patients and others is facing the biggest makeover of its three-decade history as Congress considers ways to avoid approval of drugs that don’t work.Congress is poised to amend the Food and Drug Administration’s accelerated-approval program to address complaints that it has sometimes led to the use of costly, ineffective drugs. Proposals in the House and Senate would give the FDA more authority to make sure companies conduct the large follow-up studies needed…

Danone SA DANOY 0.60% is to send the equivalent of about five million bottles of specialist infant formula to the U.S. as part of a broader push to alleviate shortages faced by babies with allergies.The French food giant said about half a million cans of specialized medical formula made by its Nutricia business will be flown into the U.S. in the coming weeks. Danone said the formula will come from its factory in Liverpool, England, which makes the Neocate line of amino…

Food and Drug Administration Commissioner Robert Califf proposed a national stockpile of baby formula that authorities could tap to ease future shortages. Dr. Califf said in a hearing Thursday before the Senate Health, Education, Labor and Pensions Committee that he expects recent government and private sector moves will produce a surplus of formula in about two months. “The question is should we maintain that surplus as a government activity…

Officials from the Food and Drug Administration and from the major formula manufacturers are expected to testify before the House Energy and Commerce Committee’s oversight and investigations subcommittee about their attempts to address the short supply. The Energy and Commerce panel oversees the FDA, which regulates baby formula. Rep. Frank Pallone (D., N.J.), chairman of the full committee, said, “The focus of this hearing will be on better understanding the causes of the shortage, what has…

WASHINGTON—Democrats, responding to public anger over the baby-formula shortage, laid out plans for legislation and oversight hearings aimed at boosting supply and preventing a repeat of the problems that left store shelves empty in many locations.The House plans to vote Wednesday on the Access to Baby Formula Act, a bill that would give emergency authority to the WIC federal nutrition program to relax some non-safety-related regulations. Democrats also unveiled a bill to provide $28 million to the Food and Drug…

U.S. health regulators cleared for use a booster shot of the Covid-19 vaccine from Pfizer Inc. and BioNTech SE for children 5 to 11 years, expanding booster access to about 28 million youngsters. The decision Tuesday by the U.S. Food and Drug Administration permits a third dose of the shot at least five months after the second dose. It comes weeks after the drugmakers said a third shot safely generated a strong immune response in the children, including…

Nestlé SA NSRGY 0.41% said it would fly extra baby formula into the U.S. from Switzerland and the Netherlands as the Gerber owner looks to accelerate deliveries to alleviate a severe shortage across the U.S. The move comes after the Food and Drug Administration on Monday said it was encouraging overseas manufacturers to apply to ship their formula to the U.S., easing rules that had effectively prevented shipments from many such…

The Food and Drug Administration authorized the first nonprescription test that can detect Covid-19, influenza and respiratory syncytial virus, or RSV. The test, developed by Laboratory Corporation of America Holdings, can be sold directly to consumers online or at retail. A person can collect a nasal-swab sample themselves before sending the sample to Labcorpfor analysis. The test, called the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, searches for and amplifies the genetic materials of multiple viruses to…

U.S. health regulators took steps to allow more foreign baby formula on American shelves, easing rules that had effectively prevented shipments from many overseas manufacturers.The Food and Drug Administration on Monday said it encouraged the overseas manufacturers to apply to ship their formula to the U.S. Government officials said the moves will allow more formula products to enter the U.S. baby market, which is dominated by Abbott Laboratories, ABT -0.15%…