The U.S. Food and Drug Administration approved Sanofi’s Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent is the first and only medicine specifically indicated to treat EoE in the United States.

The U.S. Food and Drug Administration announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications.

An advisory panel to the U.S. Centers for Disease Control and Prevention (CDC) is meeting on May 19 to discuss whether to recommend COVID-19 vaccine booster shots for children ages 5 to 11, a group that is just 29% vaccinated so far.

Reportedly, Pfizer is holding the company’s COVID-19 antiviral therapy Paxlovid under tight control. This is a disappointment to numerous investigators who want to test the antiviral combination therapy with other drugs in case the virus develops resistance to the combo.

U.S. House Democrats on May 17 unveiled a bill to provide $28 million in emergency funds to the Food and Drug Administration to help the regulatory agency respond to a nationwide shortage of infant formula and strengthen supervision of the industry.

Rising COVID-19 cases are driving up the use of therapeutics, with Pfizer Inc.’s oral antiviral treatment Paxlovid seeing a 315 percent jump over the past four weeks, U.S. health officials said on May 17.

U.S. House Democrats on May 17 unveiled a bill to provide $28 million to the Food and Drug Administration to help respond to a nationwide shortage of infant formula.

Top baby formula makers Reckitt Benckiser and Nestle ramped up supplies to the United States to resolve a shortage that has emptied shelves and caused panic among parents. Leading U.S. manufacturer Abbott Laboratories on May 16 announced an agreement with the Food and Drug Administration to resume production of baby formula at the company’s Michigan plant, marking a major step towards resolving the nationwide shortage.

The United States will allow baby formula imports from foreign makers that do not usually sell their products here, the Food and Drug Administration said on May 16, as it tries to ease a nationwide shortage that has left parents scrambling to feed their babies.

FDA

The U.S. Food and Drug Administration decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying the data has not shown the drug to be an effective therapeutic for fighting the virus.