Eli Lilly and Co. just hit another bump in the road in its quest to push deeper into treatments for skin diseases, the third setback this year for the Indianapolis-based drugmaker from the U.S Food and Drug Administration.
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Illuccix was first approved by the FDA in December 2021. The imaging agent is designed to target and “light up” cancerous cells, making it easier for oncologists to determine through a PET scan if the cells have spread to areas outside the prostate.
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The drug has been closely watched by medical professionals and is viewed by financial analysts as a possible blockbuster, with potential annual sales in the billions of dollars.
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The drug, called tirzepatide, has been closely watched by medical professionals and is viewed by financial analysts as possible blockbuster, with potential annual sales in the billions of dollars.
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The FDA had previously said Lilly’s drugs were out of shortage and that making copies must cease in October. Compounders sued, causing the FDA to pause enforcement while it reevaluated its decision.
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.
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.
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.
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.
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.
Last year’s inspection numbers were down almost 40% from the pre-pandemic period, when the FDA averaged about 4,300 annual inspections.
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.
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.
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.
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.
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.
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.
Women’s health advocates hope the decision will pave the way for more over-the-counter birth control options.
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.
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.
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.
The medication has been used by millions of Americans since the FDA granted it emergency use authorization in late 2021.
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.
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.
