FOOD AND DRUG ADMINISTRATION

Moderna has asked the FDA to authorize omicron boosters for adolescents ages 12 to 17-years-old and for kids ages 6 to 11-years-old.

The Food and Drug Administration rattled off 15 reasons behind the national baby formula shortage, but couldn't identify a specific person or agency responsible.

"We now have patients that would have died within two years of a diagnosis living 15, 20, 25, 30 years, essentially cured of their malignancies," AACR President Lisa Coussens said.

The FDA will also seek new authority to compel companies to turn over key information.

Providers have reported delays in shipments of Moderna's new shots, which make up some 20% of doses around the country.

In March, experts who advise the FDA questioned the efficacy of an experimental new drug for ALS. In September, they voted to approve it anyway.

Boiling certain medications can be harmful to breathe, let alone eat, the agency warned.

Reconfigured shots are safe, but had been delayed amid inspection of an Indiana packaging plant last month.

U.S. health regulators say their response to the ongoing infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.

A new social media trend is encouraging young people to cook their poultry in the basic ingredients of Nyquil and other over the counter cough products.

Family Dollar says it is not aware of any complaints from customers nor any reports of illnesses related to the recall.

Republicans said in a letter to the FDA commissioner that the agency needs to explain its internal procedures for investigating food safety matters

U.S. health officials are warning doctors against overusing the lone drug available to treat monkeypox.

Regulators gave Amylyx Pharmaceuticals a second chance to make a case for approving the new treatment, even though it’s still not clear it works.

A panel of federal health advisers has voted to recommend approval for an experimental drug to treat Lou Gehrig's disease.

Dr. Mehmet Oz has financial ties to suppliers of hydroxychloroquine as he backs the possible use of the anti-malaria drug to fight Covid-19.

A panel of federal health advisers has voted to recommend approval for an experimental drug to treat Lou Gehrig’s disease.

Top health officials believe the shots will provide more durable protection against Covid, but acknowledge it's not yet clear just how effective they will be.

The new shots are rolling out to pharmacies and other vaccination sites around the country.

New COVID-19 boosters targeting today’s most common omicron strains should begin arriving within days.

An advisory committee to the CDC has endorsed updated versions of the Moderna and Pfizer-BioNTech vaccines that target the original coronavirus and two omicron subvariants.

Vaccinations are expected to start next week after CDC Director Dr. Rochelle Walensky signs off.

New COVID-19 boosters that target today's most common omicron strains are set to begin soon.

Good afternoon, Chicago. Here's what is happening today.

Florida has sued federal health officials, accusing them of stalling the state's plan to import lower-cost prescription drugs from Canada.

The number of new coronavirus cases and deaths reported globally continued to fall nearly everywhere in the world in what the World Health Organization described as a “welcome decline” at a media briefing on Wednesday.

It is the first time the FDA has authorized an updated vaccine formula since the shots rolled out in December 2020.

U.S. regulators have authorized updated COVID-19 boosters, the first to directly target today's most common omicron strain.

The first shots in the Biden administration's fall booster campaign could start in days, after a vote by the CDC's advisers.

The head of the Food and Drug Administration says a government review of prescription opioid medications, including their risks and contribution to the U.S. overdose epidemic, is still underway.

COVID-19 vaccines tweaked to better match today’s omicron threat are expected to roll out in a few weeks but how much will they help.

The World Health Organization says the number of coronavirus deaths reported worldwide has fallen by 15% in the last week while new infections dropped by 9%

The House report issued Wednesday focuses on several FDA decisions in 2020, including officials’ debates over how best to expedite vaccines while ensuring they were safe and effective. But after the FDA submitted its planned timeline for approval in September 2020, Trump officials delayed the agency’s request, pressing for its justifications, prompting FDA officials to fret about the fallout. The FDA ultimately circumvented the White House on Oct. 6, publishing its vaccine guidance in briefing documents for the agency’s outside advisers. Just another political hit job!” Trump wrote on Twitter, again tagging Hahn in his tweet. “It came down to this as the most appropriate and pragmatic way to assess the vaccines,” Hahn said.

Pfizer has submitted data on its bivalent COVID-19 booster shot that specifically targets the latest omicron subvariants. If authorized, the company says the shots could be ready as soon as September.

Pfizer has asked U.S. regulators to authorize its combination COVID-19 vaccine that adds protection against the newest omicron relatives.

Pfizer asked U.S. regulators Monday to authorize its combination COVID-19 vaccine that adds protection against the newest omicron relatives — a key step toward opening a fall booster campaign. The Food and Drug Administration ordered vaccine makers to tweak their shots to target BA.4 and BA.5 that are better than ever at dodging immunity from earlier vaccination or infection. If the FDA quickly clears the combo shots made by Pfizer and its partner BioNTech, boosters could be offered within weeks.

Pfizer and its German partner BioNTech on Monday asked the Food and Drug Administration to authorize Covid booster shots that target the omicron BA.4 and BA.5 subvariants for people ages 12 and older. The U.S. is preparing for a fall vaccination campaign using updated vaccines that target the dominant omicron subvariants. The updated vaccines would target the original strain of the virus that first emerged in Wuhan, China in 2019 as well as omicron. Scientists and public health officials hope the new shots will provide broader and more durable protection against infection and mild illness. The currently authorized shots were developed to target the version of Covid that first emerged in China.

Novavax announced on Saturday that its Covid-19 vaccine has been authorized for emergency use by the FDA for adolescents between the ages of 12 and 17.

A federal court today ordered an Illinois company to stop manufacturing and distributing drugs alleged to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). In a civil complaint filed on Aug. 17, the United States alleged that Morton Grove Pharmaceuticals Inc., violated the FDCA at the company’s facility in Morton Grove, Illinois, by manufacturing and distributing adulterated drugs. Drugs not made in conformance with current good manufacturing practice regulations are adulterated and in violation of the law. “These manufacturing fundamentals are necessary to ensure the public is not put at risk from adulterated drug products. The negotiated consent decree entered by the court permanently enjoins the defendants from violating the FDCA, and requires, among other things, that the defendants stop manufacturing, processing, labeling, holding, or distributing adulterated drugs.

One maker of the fruit-flavored candies halts sales after FDA issues first-of-a-kind warning of potential toxicity.

U.S. regulators have issued a warning letter to the maker of illegal nicotine gummies.

U.S. regulators have finalized rules expected to allow millions of Americans to buy hearing aids without a prescription, starting this fall. (Aug. 16)

U.S. regulators have finalized a long-awaited rule that's expected to allow millions of Americans to buy hearing aids without a prescription.

U.S. regulators have finalized a long-awaited rule that's expected to allow millions of Americans to buy hearing aids without a prescription.

Two top anti-abortion groups have crafted and successfully lobbied for state legislation to ban or further restrict drugs used to terminate pregnancies.

Lyons Magnus is recalling 89 types of drinks over possible contamination with bacteria that causes botulism.

Previously, the FDA had advised taking two rapid antigen tests over two or three days to rule out infection. But the agency says new studies suggest that protocol can miss too many infections.

New U.S. recommendations call for three home tests for people exposed to COVID-19 to improve accuracy.

These are the stocks posting the largest moves in midday trading.

A Mississippi grand jury has declined to indict the white woman whose accusation set off the lynching of the Black teenager Emmett Till nearly 70 years ago, most likely closing the case that shocked a nation and galvanized the modern civil rights movement.

Health officials are citing research suggesting that the reduced amount is about as effective.

The Biden administration is trying to extend the limited supply of monkeypox vaccines by changing how the shot is given.

A health worker administers a dose of the Bavarian Nordic A/S Jynneos monkeypox vaccine at a vaccination site in West Hollywood, California, on Wednesday, Aug. 3, 2022. The Food and Drug Administration on Tuesday expanded its authorization for the monkeypox vaccine in a way that would significantly boost the limited supply of shots. The FDA will allow health-care providers to administer the shots through intradermal injection, which would increase the supply of doses by to fivefold. The U.S. has struggled to keep with demand for the shots as the monkeypox outbreak grows. Please check back for updates.

Nonfarm payrolls increased 528,000 for July and the unemployment rate dipped to 3.5%, both better than estimates.

The FDA is laying out a new strategy to extend vaccine supplies. But the approach doesn’t go far enough to understand how well the vaccine works.

The products being recalled range from pre-made coffees to protein shakes and other nutritional beverages. Though no illnesses have been reported, the recalled products should be thrown out.

While no illnesses have been linked to the recall, customers are advised not to consume beverages covered by it.

The FDA says trace amounts of benzene were detected in certain batches of its SPF 30 spray-on sunscreen.

The FDA has made a smart choice to delay the next vaccines for people under 50. Now, Congress needs to support the campaign by paying for them.

An atlas showing how Alzheimer's changes individual brain cells could help researchers find new treatments for the disease.

The overturning of Roe v. Wade after nearly 50 years is expected to trigger a new set of legal challenges for which there is little precedent.

The maker of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 said trace amounts of the cancer-causing chemical benzene were found in the propellant that sprays the product from the can.

U.S. regulators say they are no longer considering authorizing second COVID-19 booster shots for all adults under 50 this summer.

U.S. regulators say they are no longer considering authorizing second COVID-19 booster shots for all adults under 50 this summer.

HHS Secretary Xavier Beccerra said the federal government will announce allocations of the 786,000 vaccine doses to local authorities on Thursday.

The announcement comes amid growing criticism that authorities have been too slow in deploying the vaccine.

Health regulators say nearly 800,000 doses of monkeypox vaccine will soon be available for U.S. distribution.

U.S. officials say thousands more doses of the monkeypox vaccine could soon begin shipping from Denmark.

The U.S. is getting another COVID-19 vaccine choice.

The Food and Drug Administration, along with the Centers for Disease Control and Prevention, is helping the Florida Department of Health and Florida Department of Agriculture and Consumer Services investigate a listeria outbreak linked to ice cream, the FDA said Tuesday.

A drug company is seeking U.S. approval for the first birth control pill that women could buy without a prescription.

The Food and Drug Administration and Juul have agreed to put their court fight on hold while the government conducts more review of the company’s electronic cigarettes.

U.S. pharmacists can now prescribe the leading COVID-19 pill directly to patients.

The Biden administration is looking to help foreign manufacturers of baby formula stay on the U.S. market for the long term.

The Food and Drug Administration has issued an administrative stay on the order it issued last month for vaping company Juul to pull its electronic cigarettes from the market.

U.S. regulators are telling COVID-19 vaccine makers to tweak any booster doses intended for fall so they protect against the newest omicron relatives.

Pfizer says tweaking its COVID-19 vaccine to better target the omicron variant is safe and boosts protection.

A federal court has put a temporary hold on the government's order for Juul to stop selling its electronic cigarettes.

Health officials have ordered vaping company Juul to pull its electronic cigarettes from the U.S. market.

U.S. health regulators have ordered vaping company Juul to pull its electronic cigarettes from the market.

U.S. regulators have authorized the first COVID-19 shots for infants and preschoolers.

In a U.S. Senate committee hearing Thursday, the leaders of the Food and Drug Administration, the Centers for Disease Control and Prevention, and other public health agencies told senators that the country should prepare for what might happen next.

The first COVID-19 shots for infants, toddlers and preschoolers in the U.S. have moved a step closer.

As the federal Food and Drug Administration weighs approval of COVID-19 vaccinations for children under age 5, Florida Surgeon General Joseph Ladapo is opposed to the potential change.

A government advisory panel has endorsed a second brand of COVID-19 vaccine for school-age children and teens.

U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020.

Next week brings a marathon of hearings as the U.S. decides whether to open COVID-19 vaccinations to kids under 5.

A more traditional kind of COVID-19 vaccine is a step closer to becoming the fourth option for U.S. adults.

Abbott says it's restarted production at the Michigan factory that's tied to the ongoing baby formula shortage.

Americans may soon get a new COVID-19 vaccine option — a more traditional kind of shot known as a protein vaccine.

The head of the Food and Drug Administration testified about a series of setbacks that led to a months-long delay in inspecting the plant at the center of a nationwide baby formula shortage.

Pfizer says three small doses of its COVID-19 vaccine protect kids under 5.

Consumers should double-check their jars of Jif peanut butter amid a recall, the Food and Drug Administration and the Centers for Disease Control and Prevention say.

The Food and Drug Administration's commissioner says a shuttered baby formula factory could be up and running by next week.

The head of the Food and Drug Administration is facing congressional lawmakers for the first time over the national shortage of baby formula, the Associated Press reported Thursday.

The Food and Drug Administration's commissioner says a shuttered baby formula factory could be up and running by next week.

President Joe Biden has invoked the Defense Production Act to speed production of infant formula and has authorized flights to import supply from overseas.

The Food and Drug Administration on Tuesday approved children ages 5 to 11 to get a booster dose of Pfizer’s COVID-19 vaccine.

President Joe Biden's administration has announced new steps to ease the national shortage of baby formula, including allowing more imports from overseas.

Parents across the U.S. are scrambling to find baby formula because of supply disruptions and a massive safety recall by manufacturer Abbott.