The Latest Breaking News from FDA

'It is very unlikely that the signal would represent a true clinical risk, we believe it is important to share this information with the public'

WASHINGTON — David Kessler, a former FDA commissioner who helped steer President Joe Biden’s COVID-19 policy, will leave the administration — as the government’s response continues to gear down amid a waning pandemic and a funding crunch.

Good intentions, bad results

The U.S. Food and Drug Administration approved the medication lecanemab, sold under the brand name Leqembi, on Jan. 6, 2023, through an “accelerated approval pathway” that fast-tracks promising clinical treatments for diseases in which there are no other currently effective options.

A leading organization of pediatricians is recommending that teens with obesity be offered weight-loss medication as part of a comprehensive treatment plan. But unless barriers to access fall, it won’t move the needle on the U.S. childhood obesity epidemic — something that affects more than 1 in 5 kids in…

In a victory for animal rights advocates, drugmakers can take their products to human clinical trials using alternative testing methods that don't involve animals.

Steve Marshall says abortion patients could be prosecuted under a ‘chemical endangerment’ law, marking the first time the state’s top law enforcement official has targeted pregnant people in anti-abortion campaign

In early January 2023, the U.S. Food and Drug Administration modified its rules for mifepristone, a drug used for medication abortion, allowing it to be offered with a prescription by certified pharmacies. Before this rule change, mifepristone could be dispensed only in person by providers at hospitals, clinics and medical…

It's been six years since a startling story in The New York Times detailed how fatal opioid overdoses were tearing through rural regions of the United States "like a plow through soil." The report came as the nation was beginning to grasp that it faced the deadliest wave of drug…

On Jan. 3, the U.S. Food and Drug Administration took a first step toward making abortion pills available at retail pharmacies. It released new rules outlining how both bricks-and-mortar and mail-order pharmacies can get certified to dispense mifepristone, the first pill in a medication abortion. But the agency also left…

The Food and Drug Administration granted accelerated approval of a disease-modifying treatment that could potentially give some patients with Alzheimer's disease something they haven't had before: a medication that may slow the decline of memory and thinking.