Food and Drug Administration

WASHINGTON — The Food and Drug Administration on Wednesday announced “enhancements” under section 804 of the Federal Food, Drug and Cosmetic Act to allow states and Indian tribes to more easily import certain prescription drugs from Canada. The move, implementing... Read More

WASHINGTON — The Food and Drug Administration has directed Pfizer and Moderna to expand warning labels on their COVID-19 vaccines to include risks of a heart injury side effect associated with the mRNA shots. According to letters to Pfizer (and... Read More

WASHINGTON — President Donald Trump signed an executive order Monday aimed at reducing the time it takes the Food and Drug Administration and other agencies to approve the construction of new pharmaceutical plants in the country. The order comes as... Read More

WASHINGTON — The Food and Drug Administration announced Tuesday that it plans to end the use of petroleum-based synthetic food dyes in America’s food supply within the next two years in a bid to combat a myriad of health concerns,... Read More

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

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 has approved Dupixent (dupilumab) as the first biologic treatment for patients with uncontrolled chronic obstructive pulmonary disease and an eosinophilic phenotype. The agency approval, which was announced last week, was based on clinical... Read More

WASHINGTON — Sunco & Frenchie LCC, the Pine Brook, New Jersey, food manufacturer, is recalling batches of its Terrafina brand Golden Raisins because they may contain undeclared sulfites, the Food and Drug Administration has announced. People who have an allergy... 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 on Friday approved ARS Pharmaceuticals’ neffy epinephrine nasal spray for the emergency treatment of allergic reactions, including those that result in life-threatening anaphylaxis. Neffy is a single-dose nasal spray administered into one nostril.... Read More

WASHINGTON — The Food and Drug Administration appears poised to approve the first medicine developed specifically to treat the serious liver disease known as MASH later this week.  Metabolic dysfunction-associated steatohepatitis -- formerly known as nonalcoholic steatohepatitis — is often... 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 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 on Tuesday approved Wezlana, a biosimilar interchangeable with Stelara for the treatment of multiple inflammatory diseases. The agency said its approval of Wezlana, which is manufactured by Amgen, was based on a comprehensive... Read More

WASHINGTON (AP) — U.S. health regulators are warning consumers not to use more than two dozen varieties of over-the-counter eyedrops because of the risk of infections that could lead to blindness. The Food and Drug Administration advisory applies to lubricating drops sold... 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 — With uncertainty continuing to swirl around Capitol Hill, conversations have begun to focus not on if there will be a partial shutdown of the federal government come midnight on Saturday, but on how that almost inevitable shutdown will... Read More

WASHINGTON (AP) — The Food and Drug Administration meets this week to consider approval of an experimental treatment for Lou Gehrig’s disease, the culmination of a yearslong lobbying effort by patients with the fatal neurodegenerative disease. Those advocates still face one giant... 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 U.S. Food and Drug Administration has given its approval of the first oral medication to treat postpartum depression, a condition that is believed to impact one in seven women during the latter stages of pregnancy and after... Read More

WASHINGTON — The Food and Drug Administration on Thursday gave its first approval to a drug that can slow the progression of Alzheimer's disease. In a press release the agency said its full approval of lecanemab, known by the brand... Read More

WASHINGTON — The Food and Drug Administration on Monday released draft recommendations for tattoo ink manufacturers and distributors aimed at reducing the potential harm caused by microbial contamination. The guidance includes examples of unsanitary manufacturing and distributing conditions and provides... Read More

WASHINGTON — Top officials at the National Institutes of Health and the Food and Drug Administration are urging that more be done to advance the development of rapid drug-testing tools to stem the rising tide of overdose deaths in the... Read More

WASHINGTON — The Food and Drug Administration wants to make it easier for patients to understand why they’ve been prescribed specific medications and how to ensure they don’t suffer any preventable adverse reactions when taking them. Toward that end the... Read More

ATLANTA — A fourth death has been linked to a recalled brand of artificial tears made by EzriCare and Delsam Pharma, as the number of infections with a highly drug-resistant bacteria grew to 81 across 18 states, the Centers for... Read More

WASHINGTON — The Food and Drug Administration on Wednesday licensed the first-ever vaccine for respiratory syncytial virus, or RSV, a highly contagious virus that is a common cause of lower respiratory tract disease in older adults. The vaccine, Arexvy, was... Read More

WASHINGTON — The Food and Drug Administration on Monday conditionally approved Varenzin-CA1, the first drug for the control of nonregenerative anemia associated with chronic kidney disease in cats.  Nonregenerative anemia is a potentially fatal condition in which a cat’s bone... Read More