Food and Drug Administration

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

WASHINGTON — The Food and Drug Administration on Wednesday approved the first oral fecal microbiota treatment for preventing recurrent Clostridium difficile colitis infections in adults. Clostridium difficile colitis, caused by the bacterium C. difficile, is one of the most common... 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

WASHINGTON — The U.S. Food and Drug Administration on Thursday updated its regulations on mammography in an effort to strengthen the agency’s oversight and detect and treat breast cancer earlier. The rule that went into effect March 9 amended regulations... Read More

WASHINGTON — A panel of advisors to the Food and Drug Administration narrowly voted on Tuesday to endorse an experimental vaccine from Pfizer to protect older adults against the highly contagious lower respiratory tract ailment RSV. The advisors voted 7-4... Read More

WASHINGTON — The Food and Drug Administration has approved the first combination test for flu and COVID-19 that can be used at home. The test from Lucira Health, which can be purchased without a prescription, can detect influenza A and... Read More

WASHINGTON — An abortion pill previously available only from a certified doctor, clinic or two online pharmacies will soon be obtainable at local pharmacies with a prescription, the Food and Drug Administration announced Tuesday. Mifepristone is the first of two... Read More

WASHINGTON — The Food and Drug Administration on Thursday amended its emergency use authorizations for the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines, saying the shots are safe to administer to children as young as 6 months old. “More children... Read More

WASHINGTON — Sens. Patty Murray, D-Wash., and Richard Burr, R-N.C., have struck a deal on language that will allow the reauthorization of the Food and Drug Administration’s user fee program to move forward as part of the continuing resolution Congress... Read More

TAMPA, Fla. — Florida's governor announced Wednesday his state is suing the Food and Drug Administration to speed up permission to import drugs from Canada. Canadian drugs for diabetes, hepatitis C and other common illnesses are less expensive than most... Read More

WASHINGTON — The Food and Drug Administration on Wednesday authorized updated COVID-19 booster shots specifically targeting a subvariant of omicron. The agency approved two options aimed at the BA.5 subvariant of omicron that is now dominant in the U.S.: one... Read More

WASHINGTON — Pfizer and its German partner, BioNTech, asked the Food and Drug Administration Monday to authorize COVID booster shots that target the omicron BA.4 and BA.5 subvariants for people aged 12 and older. The request came less than a... Read More

WASHINGTON — More than 4.8 million cans of infant formula will be shipped to U.S. retailers from an Australian manufacturer beginning in August, the Food and Drug Administration announced Friday. The formula is being sourced from Care A2+, an Australian-owned... Read More

WASHINGTON — A federal appeals court on Friday stayed the Food and Drug Administration's ban on sales of Juul Labs Inc's e-cigarettes, after the company appealed the agency's order on the grounds the ban would cause it "irreparable harm." The... Read More

WASHINGTON — The Food and Drug Administration on Thursday ordered Juul Labs to pull its electronic cigarettes from the U.S. market, a move intended to curb a multibillion-dollar industry blamed for sparking a national surge in teen vaping.  "Today's action... Read More