FDA seeks public input on how to design early trials of ibogaine
The FDA asked for comments by Nov. 20 on how early clinical trials of the psychedelic ibogaine should be designed.
Science and Technology
A thyroid compound once barred as a diet supplement returns as an approved rare-disease drug
The FDA on Monday approved tiratricol, sold as Emcitate by Sweden's Egetis Therapeutics, for MCT8 deficiency, a genetic disorder estimated to affect about 1…
FDA opens door to rewriting its vape and pouch approval rules
The FDA said Monday it will consider replacing the 2021 rule that governs how new e-cigarettes, nicotine pouches and other tobacco products win permission…
What shoppers at 54 Midwest locations should know about the Gold Star recall
Shelf-stable products from Gold Star Distribution's Minneapolis warehouse went to 54 stores, restaurants and other locations, all but two in Minnesota, with…
A decade of rodent findings came before a court shut a Minneapolis warehouse
State and federal inspectors documented rodent problems at Gold Star Distribution's Minneapolis warehouse for more than a decade before a federal court…
FDA rewrites its rules so drug safety testing no longer defaults to animals
The FDA has updated its drug regulations to make clear that developers may use non-animal methods, such as tests on human cells, organs-on-chips and…
First treatment approved for Sanfilippo syndrome, a fatal childhood disease
The FDA on Sept. 17 approved Fayuvi, from Ultragenyx, as the first treatment for Sanfilippo syndrome type A, a rare, fatal inherited disease that erodes…
FDA pilot aims to speed the first human tests of new drugs
The FDA has opened applications for a pilot program meant to speed first-in-human drug trials in the United States, which the agency says can take up to two…
Why premature babies' first IV nutrition is at risk, and what the FDA is doing
The FDA has temporarily eased compounding rules after children's hospitals warned they could lose access to starter IV nutrition, the premixed dextrose,…
FDA approves a blood-test-guided switch for a common advanced breast cancer
The FDA on Sept. 4 granted accelerated approval to AstraZeneca's Etcamah (camizestrant), taken with a CDK4/6 inhibitor, for adults with advanced hormone…
FDA approves a first-of-its-kind pill that nearly doubled median survival in an advanced pancreatic cancer trial
The FDA has approved Rasonque (daraxonrasib), a daily pill from Redwood City, Calif.-based Revolution Medicines, for adults whose pancreatic adenocarcinoma…