Trump efficiency guru Ramaswamy could benefit from crusade against FDA
Vivek Ramaswamy owns about $670 million in shares of Roivant Sciences, which is pursuing studies for three drugs that could land before the FDA during Donald Trump’s second term.
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Amid backlash, FDA changes course over shortage of Lilly weight-loss drugs
The U.S. Food and Drug Administration said it would not take enforcement action—for now—against pharmacies making their own versions of weight-loss drugs based on Eli Lilly’s tirzepatide.
Bakery that makes Sarah Lee, Entenmann’s pushes back on FDA sesame warning
Bimbo Bakeries USA appears to be defying an FDA warning sent in June that said the several of the company’s products are “misbranded” because the labels list sesame or tree nuts even though those ingredients aren’t in the foods.
Lilly seeks court ruling that could mean big money for new weight-loss drug
The Indianapolis-based drugmaker filed a suit in federal court this month, challenging the U.S. Food and Drug Administration’s ruling that the company’s experimental obesity treatment not a biological product.
Teen vaping hits 10-year low in United States
FDA officials noted that the drop in vaping didn’t coincide with a rise in other tobacco industry products, such as nicotine pouches, which have surged in use among adults.
Nearly 2,000 drug plants overdue for FDA checks after COVID delays, analysis finds
Last year’s inspection numbers were down almost 40% from the pre-pandemic period, when the FDA averaged about 4,300 annual inspections.
FDA reverses ban on Juul products as Supreme Court decision awaits
The FDA said Thursday that the move to rescind the ban was made in light of court cases involving the vaping industry and because the agency has since “gained more experience” with scientific issues involving e-cigarette products.
Lilly girding for questions over Alzheimer’s treatment from FDA committee
The U.S. Food and Drug Administration is convening a panel of independent experts on June 10 to discuss donanemab’s safety and effectiveness, including the results in patients in a clinical trial.
FDA to bring lab tests under federal oversight in bid to improve accuracy, safety
The goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and many other illnesses are safe, accurate and reliable.
Precut cantaloupes linked to ‘severe’ salmonella outbreak, CDC says
There have been 117 salmonella cases in people across 34 U.S. states, according to the CDC. Two people have died, and at least 61 people have been hospitalized.
FDA approves Lilly’s diabetes drug for weight management
Eli Lilly and Co.’s hot-selling diabetes drug, Mounjaro, will now be sold for a second use, chronic weight management, using a separate brand name, Zepbound.
Popular nasal decongestant doesn’t actually relieve congestion, FDA advisers say
The leading decongestant used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, according to government experts.
First over-the-counter birth control pill gets FDA approval
Women’s health advocates hope the decision will pave the way for more over-the-counter birth control options.
FDA advisers endorse updating COVID vaccines to target latest omicron strain
On Thursday, the Food and Drug Administration’s scientific advisers said the next round of shots in the U.S. should only include protection against the newest variants that are now dominant worldwide—a branch of the omicron family tree named XBB.
Medicare to expand coverage for new class of costly Alzheimer’s drugs
Groups such as the Alzheimer’s Association have pushed Medicare to cover the new Alzheimer’s drugs—including those cleared on an expedited basis—saying that the FDA should be the final arbiter of safety and efficacy of drugs.
Texas judge suspends FDA approval of abortion pill mifepristone
A federal judge in Texas blocked U.S. government approval of a key abortion medication Friday, siding with abortion foes in an unprecedented lawsuit and potentially upending nationwide access to the pill widely used to terminate pregnancies.
COVID-19 pill Paxlovid moves closer to full FDA approval
The medication has been used by millions of Americans since the FDA granted it emergency use authorization in late 2021.
Herbal painkiller kratom could become legal again in Indiana
Kratom was legal in Indiana until 2014, when state lawmakers banned the substance in anticipation of similar action at the federal level. But the FDA has failed to outlaw kratom, despite numerous attempts.
FDA’s own reputation could be restraining its misinformation fight
The U.S. Food and Drug Administration is taking aim at a new health hazard: online misinformation. It’s an unlikely role for the 100-year old bureaucratic agency, which has never been known for its communication skills.
Panel backs moving opioid antidote Narcan over the counter
The potential move represents the latest government effort to increase use of a medication that has been a key tool in the battle against the U.S. overdose epidemic that kills more than 100,000 people annually.