Probe: Alzheimer’s drug approval ‘rife with irregularities’
The Food and Drug Administration’s contentious approval of Alzheimer’s drug Aduhelm took another hit Thursday as congressional investigators questioned the integrity of the process.
FDA
Articles
Scathing report urges major changes at FDA, including possibly breaking up agency
The report comes in the wake of heavy criticism of the agency’s handling of a formula shortage earlier this year. Food safety experts have long complained that the agency’s food oversight arm has been chronically understaffed and underfunded.
FDA announces new definition of what’s ‘healthy’
The proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans.
FDA panel backs much-debated ALS drug in rare, second review
The ruling Wednesday was a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year.
USDA getting tougher on salmonella in chicken products
The salmonella bacteria sickens 1.3 million Americans each year, sends more than 26,000 of them to hospitals and causes 420 deaths, according to Centers for Disease Control and Prevention data.
How canine heart disease was tied to grain-free dog food—without a firm link
The FDA has found no firm link between diet and dilated cardiomyopathy. Nor has it rejected such a link, and research is ongoing. Publicity surrounding this issue, nevertheless, has shrunk the once-promising market for grain-free dog foods.
Juul, FDA suspend court case while e-cigarette ban on hold
The agreement comes one day after the FDA placed a hold on its initial order banning Juul’s products from the market, saying that Juul’s application warranted “additional review.”
FDA advisers recommend updating COVID booster shots for fall
An FDA panel voted 19-2 that COVID-19 boosters should contain some version of the super-contagious omicron variant, to be ready for an anticipated fall booster campaign.
FDA bans Juul e-cigarettes tied to teen vaping surge
The action is part of a sweeping effort by the Food and Drug Administration to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays.
Pressure growing to remove PFAS from fast food wrappers
Known as “forever chemicals” for their persistence in the environment, PFAS have been used for decades to prevent grease, water and other liquids from soaking through wrappers, boxes and bags.
FDA chief struggles to explain slow response on baby formula
The FDA and President Joe Biden face mounting political pressure to explain why they didn’t intervene sooner to head off the supply crisis.
FDA head: Baby formula factory could reopen by next week
FDA Commissioner Dr. Robert Califf faced a bipartisan grilling from House lawmakers over the baby formula issue that has angered American parents and become a political liability for President Joe Biden.
Parents hunting for baby formula as shortage spans U.S.
Months of spot shortages at pharmacies and supermarkets have been exacerbated by the recall at Abbott, which was forced to close its largest U.S. formula manufacturing plant in February due to contamination concerns.
E-cigs using synthetic nicotine come under FDA oversight
U.S. regulators will soon begin cracking down on vaping companies using a now-closed loophole, including a line of fruit-flavored e-cigarettes that have become teenagers’ top choice.
Lilly says it will push ahead on Alzheimer’s drug
The push by Eli Lilly and Co. will come despite an unfavorable ruling last week from Medicare that sharply restricts reimbursements for a drug in the same class.
FDA approves another Pfizer, Moderna COVID booster for those 50 and up
The latest expansion, regardless of people’s health, allows an extra shot to millions more Americans—and the question is whether everyone who’s eligible should rush out and get it.
FDA skeptical of benefits from experimental ALS drug
On Wednesday, a panel of FDA advisers will take a non-binding vote on whether the drug warrants approval. The meeting is being closely watched as an indicator of the FDA’s approach to experimental drugs with imperfect data and its ability to withstand outside pressure.
Pressured by patients, FDA reviews ALS drug with modest data
Experts who study FDA decision-making see a troubling pattern in which the beleaguered agency is continually pressured to accept weaker evidence, damaging its scientific credibility and opening the door to ineffective treatments.
FDA expected to sharply restrict use of monoclonal antibodies made by Lilly, Regeneron
The Food and Drug Administration is poised as soon as Monday to restrict two monoclonal antibodies, saying the COVID-19 treatments should not be employed in any states because they are ineffective against the dominant omicron variant, according to two senior administration health officials.
Purdue-based startup gets FDA approval for cancer-targeting drug
It’s a big moment for On Target Laboratories, an 11-year-old biotech based in West Lafayette. The FDA approval marks the company’s first novel compound to get across the finish line. The drug is marketed under the brand name Cytalux.