Juul Asks Court to Block FDA Ban on Its E-Cigarettes

Juul Labs Inc. asked a federal appeals court on Friday to temporarily block the Food and Drug Administration’s order that the vaping company pull its e-cigarettes off the U.S. market. In a filing with the U.S. Court of Appeals for the D.C. Circuit, the company asked for an administrative stay until it can petition the … Read more

Latest Report of Baby’s Death After Consuming Formula Mentions Cronobacter Bacteria

The latest report notifying federal health regulators that a baby died after it had consumed Abbott Laboratories ’ baby formula mentions the cronobacter bacteria, the Food and Drug Administration said. Cronobacter is the same bacteria that previously sickened at least four other infants, including two who died, between September 2021 and February after they had … Read more

FDA Investigating Report of Baby’s Death After Consuming Abbott Baby Formula

The Food and Drug Administration is investigating a new report of another child’s death after consuming Abbott Laboratories’ baby formula, the agency said Wednesday. The FDA said it learned about the death, which occurred in January, from a consumer complaint it received on June 10. The FDA said its investigation is in preliminary stages, and … Read more

Americans With ALS Look to Canada for Promising Drug the U.S. Hasn’t Approved

Canada approved Amylyx Pharmaceuticals Inc.’s new drug for amyotrophic lateral sclerosis last week. Now some U.S. patients with the fatal neurodegenerative disorder—also known as Lou Gehrig’s disease—are considering a trip north to get the medication, Albrioza. The drug isn’t approved in the U.S. William Woods, a 75-year-old retired doctor in Atlanta who was diagnosed with … Read more

WSJ News Exclusive | FDA to Order Juul E-Cigarettes Off U.S. Market

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FDA Authorizes First Covid-19 Vaccines for Young Children

Some 1½ years after first authorizing the shots for people of older ages, the Food and Drug Administration on Friday expanded use of the vaccines to the nearly 20 million children in the U.S. from 6 months to under 5 years. A national campaign to vaccinate the young children is expected to kick off as … Read more

Canada Approves Amylyx’s ALS Drug as U.S. Seeks More Time to Review

Canadian health authorities approved Amylyx Pharmaceuticals Inc.’s new drug for amyotrophic lateral sclerosis, the progressive neurodegenerative disease that robs patients of their ability to move and speak. It is the first Canadian approval since 2018 for a new drug treating the fatal condition, which is also known as Lou Gehrig’s disease. The action by Health … Read more

Three-Dose Pfizer Covid Vaccine Works Safely in Young Children, Review Says

The FDA staff also said, in a review of study data posted online Sunday, that there were no new safety concerns using the vaccine in young children compared with older age groups. The assessment is the latest sign that authorities are moving closer to clearing inoculations for children under 5 years old, the last group … Read more

WSJ News Exclusive | Biden Administration to Pursue Rule Requiring Less Nicotine in U.S. Cigarettes

The White House effort to require reduced nicotine levels in cigarettes would upend the tobacco industry. Photo: Mario Tama/Getty Images Updated June 10, 2022 7:44 pm ET The Biden administration intends to pursue a policy requiring tobacco companies to reduce the nicotine in all cigarettes sold in the U.S. to minimally or nonaddictive levels, according … Read more

Moderna’s Covid-19 Vaccine Works Safely in Kids, Including Those Under Age 5, FDA Says

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 … Read more