The head of the Food and Drug Administration plans to start offering bonus payments to agency drug reviewers who complete their work ahead of the schedule.
The Food and Drug Administration is proposing a system for approving customized drugs and medical treatments for patients with rare or hard-to-treat diseases.
The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.
Vaccine maker Moderna says the Food and Drug Administration will decide whether to approve its new flu shot for older adults after all.
A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs.
The Food and Drug Administration (FDA) is recalling shredded cheese sold in 31 states and Puerto Rico because it may contain metal fragments.
The Food and Drug Administration says it will remove a long-standing warning from hormone-based drugs used to treat menopause symptoms in women.
The head of the Food and Drug Administration’s drug center abruptly resigned Sunday amid concerns about his personal conduct.
Federal regulators are trying to make it easier to develop cheaper alternatives to powerful drugs that many Americans depend on to treat autoimmune diseases or cancers.
The Food and Drug Administration is announcing the first round of drugs that will receive drastically expedited reviews at the agency.
Federal health officials have approved another generic version of the abortion pill, prompting outrage from abortion opponents.
A Trump administration decision to repurpose an old chemotherapy drug for autism has surprised many experts — including the physician who recently proposed the idea.
The Trump administration has issued its first warnings to online services that offer unofficial versions of popular drugs like the blockbuster obesity treatment Wegovy.
A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules and promoting fringe views about antidepressants and other products.
U.S. health officials have issued warnings on two separate Boston Scientific heart devices recently linked to injuries and deaths.
U.S. health officials are cracking down on an opioid-related ingredient being added to drinks, supplements and other products.
Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy.
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators.
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy.
A top official at the Food and Drug Administration recently overruled government scientists on the availability of two COVID-19 vaccines.
The Supreme Court is siding with e-cigarette companies in a ruling that'll make it easier to sue over Food and Drug Administration decisions blocking their products from the multibillion-dollar vaping market.
The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump administration priorities for Americans' health.
Health officials want you to think twice before buying brightly colored energy shots and supplements often sold at gas stations, convenience stores and smoke shops.
Government advisers are split on whether drugmakers should update their COVID-19 vaccines to better protect Americans this fall and winter.
U.S. health officials are announcing an effort to phase out ingestible fluoride supplements used to strengthen children’s teeth, citing possible health risks.
The FDA says it will allow three new color additives made from natural sources to be used in the nation's food supply.
President Donald Trump's administration has asked a judge to toss out a lawsuit from three Republican-led states seeking to cut off telehealth access to the abortion medication mifepristone.
The Food and Drug Administration is again trying to rehire some staffers who were recently fired amid mass layoffs at the agency.
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from Novavax.
Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the Food and Drug Administration.
While in India on Tuesday, U.S. Vice President JD Vance called for enhanced engagement with the South Asian country.
A draft budget proposal circulating among federal officials would dramatically deepen cuts at the nation’s top health agency, eliminating some public health programs entirely and serving as a roadmap for more mass firings.
A former top vaccine official says he was forced out of government after trying to block Robert F.
The Campaign for Tobacco-Free Kids says the Supreme Court's ruling for the Food and Drug Administration in its crackdown on sweet-flavored vaping products is “a major victory for the health of America’s kids.”.
Employees across the massive U.S. Health and Human Services Department received notices Tuesday that their jobs were being eliminated, part of a sweeping overhaul designed to vastly shrink the agencies responsible for protecting and promoting Americans’ health.
The top vaccine official with the Food and Drug Administration has resigned and criticized the nation's top health official for allowing “misinformation and lies” to guide his thinking behind the safety of vaccinations.
A Democratic senator says she's worried about the fallout from a major overhaul and layoffs at the U.S. Department of Health and Human Services.
A pill used in most U.S. abortions has been ensnared in politics for years, and many Americans wonder whether it will be restricted under the new Republican administration in Washington.
The Food and Drug Administration is asking retailers to remove a small number of acne creams from their shelves that contain slightly elevated levels of a chemical linked to cancer.
The Food and Drug Administration has upgraded the recall for broccoli sold at Walmart stores in 20 states to its most serious risk level more than one month after the recall was originally issued.
A startling discovery by the FDA reveals that some over-the-counter supplements marketed as “natural” remedies for male enhancement may secretly contain hidden pharmaceuticals, potentially putting millions of men at risk.
A federal judge in Texas is allowing three other states to pursue a challenge seeking to restrict access to the abortion pill mifepristone nationwide.
Federal health officials are backing the health benefits of nicotine pouches, ruling that Philip Morris International’s Zyn can help adult smokers cut back or quit cigarettes.
The Food and Drug Administration is ordering food and drug makers to remove a dye called Red 3 from the products U.S. consumers eat and drink.
The Biden administration is floating a long-awaited proposal to make cigarettes less addictive by capping their nicotine levels.
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for patients of color.
Senate Republican leader Mitch McConnell, a childhood polio survivor, said any of President-elect Donald Trump’s picks requiring Senate confirmation should “steer clear” of efforts to discredit the polio vaccine.
A majority of Supreme Court justices didn’t seem convinced Monday that federal regulators misled companies before refusing to allow them to sell sweet flavored vaping products following a surge in teen e-cigarette use.
Vaping is coming before the Supreme Court next week as federal regulators ask the high court to uphold its block on sweet, flavored products following a spike in youth e-cigarette use.
The Supreme Court won’t hear a challenge to a federal requirement that cigarette packages and advertising include graphic images demonstrating the effects of smoking.
President-elect Donald Trump has nominated a critic of COVID-19 health measures to lead the Food and Drug Administration.
Nationally, 22 people have been hospitalized, the CDC said. Two people developed a dangerous kidney disease complication and one person died.
Deadly food poisoning outbreaks tied to McDonald's and Boar's Head may have left Americans wondering whether there are new risks in the U.S. food supply.
A top U.S. commercial bakery is pushing back on a Food and Drug Administration warning to stop using labels that say its products contain sesame — even when they don't.
Two U.S. House members who first pushed the Food and Drug Administration in 2023 to investigate the health risks of hair straighteners used primarily by Black women are asking the agency why it has twice delayed its target date to propose a ban on products containing formaldehyde.
U.S. health officials have approved the first nasal spray to treat severe allergic reactions, offering an alternative to injectable products like EpiPen.
U.S. health officials are warning that several types of ground cinnamon sold at certain discount and specialty grocery stores are contaminated with high levels of lead.
Military veterans have spent years lobbying for the use of psychedelic drugs to treat PTSD, but a sharply critical review of the club drug MDMA has put the therapy's approval in doubt.
Federal health officials have authorized sales of Vuse Alto, the best-selling e-cigarette in the U.S. The Food and Drug Administration made the decision Thursday, allowing Reynolds American to keep its reusable e-cigarette on the market for years to come.
As COVID-19 bubbles up in some parts of the country, health officials are setting course for a fall vaccination campaign.
The Michigan Department of Health and Human Services (MDHHS) and the Food and Drug Administration (FDA) are urging Michigan residents not to eat, sell, or serve any flavor of Diamond Shruumz-brand Microdosing Chocolate Bars, Infused Cones or Micro Dose and Macro Dose gummies, and instead throw them away.