FDA bans red dye No. 3 from foods
Food manufacturers will have until January 2027 to remove the dye from their products, while makers of ingested drugs have until January 2028 to do the same.
FDA
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FDA rejects Lilly drug for eczema due to inspection issues at outside manufacturer
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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Fishers biotech firm lands additional FDA approval for imaging product
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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FDA approves Lilly diabetes drug that helps patients lose weight
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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Lilly says experimental drug helped patients lose up to 22% of body weight
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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Articles
Controversial red dye used in candy, drinks and snacks could soon be banned
The Food and Drug Administration is on the cusp of deciding whether to ban a controversial bright cherry-red dye that has been linked to cancer in animals.
FDA proposes new testing rules to ensure cosmetics are asbestos-free
The proposal from the Food and Drug Administration and mandated by Congress is intended to reassure consumers about the safety of makeup, baby powder and other personal care products.
FDA set to phase out leading decongestant in many cold medicines
Phenylephrine is used in popular versions of Sudafed, Dayquil and other medications, but experts have long questioned its effectiveness.
Lilly’s U.S. weight-loss drug shortage ends, curtailing copycats
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.
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.
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.