FDA

WASHINGTON — The Trump administration is launching a renewed effort to ensure the “ongoing quality, safety, nutritional adequacy and resilience” of the infant formula supply in the United States. The initiative, dubbed “Operation Stork Speed,” is a collaborative effort between... Read More

WASHINGTON — Health and Human Services Secretary Robert F. Kennedy Jr. directed the Food and Drug Administration this week to begin the process of eliminating chemicals “generally regarded as safe” from the nation’s foods. In a video posted to the... Read More

WASHINGTON — Two months after finalizing a rule updating the nutritional requirements foods must meet to be labeled “healthy,” the Food and Drug Administration is pushing back its effective date. The final rule was to have gone into effect on... Read More

WASHINGTON (AP) — Federal officials on Wednesday released a far-reaching proposal to make cigarettes less addictive by capping their nicotine content, a goal long sought by antismoking advocates that is unlikely to go into effect anytime soon. The proposed rule from the Food and Drug... Read More

SOLEDAD, Calif. — A voluntary recall of certain broccoli florets has been issued as a precaution due to the possibility of a shipment of the vegetables being contaminated with Listeria monocytogenes. The recall was issued by Braga Fresh for its... Read More

WASHINGTON — The Food and Drug Administration on Friday approved the first engineered vessel made from acellular tissue for the treatment of extreme arterial injuries when other steps can’t be taken to avoid imminent limb loss. Symvess, manufactured by Humacyte... Read More

WASHINGTON — The Food and Drug Administration on Thursday said it is raising the minimum age for certain restrictions on the sale of tobacco products. The new rule, which will be published in the Federal Register on Friday, states that... Read More

WASHINGTON — The Food and Drug Administration has approved a new screening test for colorectal cancer that requires only a small sample of blood to detect the presence of cancers, even at their early stages when they are most treatable.... Read More

WASHINGTON — The Food and Drug Administration on Monday updated its draft guidance on how health care industry companies can better spike misinformation related to their agency-approved or cleared medical products. “Regulated industry plays a critical role in ensuring consumers... Read More

WASHINGTON — The Justice Department and the Food and Drug Administration are the leads on a new multi-agency task force intended to crack down on the illegal distribution and sale of e-cigarettes. Also participating in the task force are the... Read More

WASHINGTON (AP) — Federal health regulators and law enforcement officials on Monday vowed to work more closely to stop sales of illegal electronic cigarettes, which have grown into a multibillion-dollar business in the U.S. while skirting government oversight. The Food and Drug... Read More

WASHINGTON — The Food and Drug Administration on Wednesday approved the drug Zevtera for the treatment of adults with certain bloodstream infections, those with acute bacterial skin and skin structure infections, and adult and pediatric patients 3 months to less... Read More

WASHINGTON — The Food and Drug Administration warned consumers on Tuesday not to use certain over-the-counter pain relief products marketed for topical use before, during or after certain cosmetic procedures. The warning came after the agency issued warning letters to... Read More

WASHINGTON — The Food and Drug Administration has unveiled a new website detailing the Foods Program regulations it plans to publish through October 2024. The web portal, which will also list longer-term regulations the agency is prioritizing for publication at... Read More

WASHINGTON — The Food and Drug Administration on Friday authorized Florida to purchase millions of dollars' worth of medications from Canada, a move long opposed by the pharmaceutical industry. The goal of the approval is to give states access to... Read More

WASHINGTON — A popular hypoallergenic infant formula has been voluntarily recalled by its manufacturer due to possible Cronobacter sakazakii contamination. The formula, Nutramigen Hypoallergenic Infant Formula Powder, is manufactured by Reckitt/Mead Johnson Nutrition. According to an alert issued by the... Read More

WASHINGTON — The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology for the treatment of sickle cell disease. The new treatment, called Casgevy, was manufactured by Vertex Pharmaceuticals, of Boston, Massachusetts, and... Read More

WASHINGTON — The Food and Drug Administration on Tuesday approved Ogsiveo tablets for adult patients with progressing desmoid tumors, a rare subtype of soft tissue sarcomas. Desmoid tumors are non-cancerous but can be locally aggressive, invading surrounding structures and organs,... Read More

WASHINGTON — The Food and Drug Administration has approved the sale of the first over-the-counter antigen test for COVID-19. The product, ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home... Read More

WASHINGTON — The Food and Drug Administration is creating a new Digital Health Advisory Committee to help the agency assess and deal with the complex scientific and technical issues related to the burgeoning market of new digital health technologies. These... Read More

WASHINGTON — The Food and Drug Administration on Tuesday amended its emergency use authorization for the Novavax COVID-19 vaccine, approving an updated version of the vaccine for use by previously vaccinated individuals aged 12 and older. Of course, those who... Read More

WASHINGTON — The Food and Drug Administration has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing... Read More

WASHINGTON — A common decongestant ingredient used in many popular over-the-counter medications simply doesn’t work, an advisory panel to the Food and Drug Administration said Tuesday, potentially setting the stage for a sweeping removal of many cold and flu remedies... Read More

WASHINGTON — The Food and Drug Administration on Monday approved the use of updated COVID-19 vaccines to provide the public with additional protection against the virus ahead of a potential winter bump in cases. One thing the FDA did not... Read More

WASHINGTON — The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription in the United States.  The agency’s approval of the over-the-counter medication this morning is a first, and is seen as... Read More

WASHINGTON — The Food and Drug Administration on Friday published a new draft guidance on what researchers should consider when investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders.  The first-of-its-kind... Read More

WASHINGTON — A panel of federal health advisors voted unanimously on Wednesday to approve the first over-the-counter sale of a medical contraceptive. The vote came at the end of a two-day meeting during which the panel, which offers nonbinding recommendations... Read More

WASHINGTON — The Food and Drug Administration on Tuesday issued an emergency use authorization for Gohibic (vilobelimab) injections to be used to treat COVID-19 in hospitalized adults. The authorization allows for the use of the injection within 48 hours of... Read More

MINNEAPOLIS (AP) — Minnesota Attorney General Keith Ellison is slated to lead off opening statements expected for Tuesday in his state's lawsuit against Juul Labs – marking the first time any of the thousands of cases against the e-cigarette maker... Read More

BOSTON — Encouraged by positive topline results from its phase 3 trial for its new therapy for adults with schizophrenia, Karuna Therapeutics announced Monday that it is on track to submit KarXT to the Food and Drug Administration for approval... Read More