Tag Archives: FDA

Reuters reports: The U.S. Food and Drug Administration granted expanded approval to Emergent BioSolutions’ smallpox vaccine for use in people at high risk of mpox infection, sending the drugmaker’s shares 5% higher on Friday. The FDA clearance, announced late on Thursday by the company, makes the vaccine – called ACAM2000 – the second approved shot against mpox in the U.S. …

NBC News reports: The Food and Drug Administration on Thursday approved the new Covid vaccine from Pfizer and Moderna. It’s the third time the vaccines have been updated to match circulating strains since the original series. The shots should be available within days. The agency hasn’t yet approved a third vaccine, from drugmaker Novavax. The timing of the new vaccines …

NBC News reports: The Food and Drug Administration on Friday granted marketing authorization to the first at-home, over-the-counter test to detect syphilis antibodies in human blood in a move that could help boost screening rates for the sexually transmitted disease. Developed by privately held NOWDiagnostics, the antibody test helps identify current or past infection and provides a result in about …

NBC News reports: The Food and Drug Administration on Monday approved Guardant Health’s blood test, called Shield, to screen for colon cancer. The test isn’t meant to replace colonoscopies, but is generating enthusiasm among doctors who say it has the potential to boost the dismal rate of screenings for the second-highest cause of cancer death in the United States. Shield …

CNBC reports: The Food and Drug Administration on Tuesday approved Eli Lilly’s Alzheimer’s drug donanemab, expanding the limited treatment options for the mind-wasting disease in the U.S. The agency approved the treatment, which will be sold under the brand name Kisunla. Eli Lilly’s drug slowed Alzheimer’s progression by 35% over 18 months compared with a placebo, according to a late-stage …

The New York Times reports: A committee of independent advisers to the FDA voted unanimously on Monday that the benefits outweigh the risks of the newest experimental drug for Alzheimer’s disease. Alzheimer’s afflicts more than six million Americans. It has no cure, and there is no treatment or lifestyle modification that can restore memory loss or reverse cognitive decline. The …

NPR reports: A panel of experts advising the Food and Drug Administration on the use of the psychedelic MDMA for post-traumatic stress disorder found on Tuesday that the available evidence fails to show that the drug is effective or that its benefits outweigh its risks. It represents a major setback for proponents of the drug and its sponsor Lykos Therapeutics, …

NBC News reports: The Food and Drug Administration’s panel of independent advisers will on June 4 deliberate whether they should recommend approval for the first MDMA-assisted therapy for post-traumatic stress disorder, Lykos Therapeutics said on Monday. This would be the first FDA panel of outside experts to review a potential new PTSD treatment in 25 years. In support of its …

Media Matters reports: The Daily Wire announced the launch of a new “men’s lifestyle” company named Responsible Man on May 1, promoting its only current product — a men’s dietary supplement that it says is “designed to help … sharpen brain cognition” and that it suggests will help address what the outlet calls the “increasing health risk” of declining “sperm …

Fierce Biotech reports: After more than a year in the works, Roche and Eli Lilly have taken a step closer to delivering their blood test designed to aid in the diagnosis of earlier cases of Alzheimer’s disease. The FDA has granted their work a breakthrough designation to help accelerate its development. Roche’s Elecsys plasma assay searches for and quantifies phosphorylated …

Reuters reports: A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon Musk’s Neuralink before allowing the brain implant company to test its device in humans. Reuters reported last month that FDA inspectors found problems with record keeping and quality controls for animal experiments at Neuralink last June, less than …

NBC News reports: Family Dollar Stores was this week ordered to pay $41.6 million for using a rodent-infested warehouse to distribute food, cosmetics and medical devices to more than 400 stores across the South. The largest criminal penalty of its kind comes after a U.S. Food and Drug Administration investigation found “live rodents, dead and decaying rodents, rodent feces, urine, …

Axios reports: The Food and Drug Administration on Friday approved a plan allowing Florida to import cheaper prescription drugs from Canada, opening the door for states to buy direct from pharmacies there to stock their state-run health programs. The approval, the first of its kind, allows the Biden administration to show it’s addressing a major voter concern in an election …

The Washington Post reports: Americans’ life expectancy decline remains a pressing public health problem — but not a political priority. The Washington Post spoke with more than 100 public health experts, lawmakers and senior health officials, including 29 across the past three presidential administrations, who described the challenges of attempting to turn around the nation’s declining life expectancy. Those challenges …

The Washington Post reports: A U.S. inspection of a plant in Ecuador that manufactured pouches of contaminated applesauce linked to at least 125 cases of suspected lead poisoning in children found “extremely high” levels of the metal in a key ingredient: cinnamon. The Food and Drug Administration said Monday that samples of cinnamon from the plant that were tested contained …

NBC News reports: The lead contamination in recalled cinnamon applesauce pouches that potentially poisoned at least 65 children may have been intentional, the Food and Drug Administration said on Friday. The FDA has been investigating the lead contamination in the cinnamon-flavored applesauce products from Florida-based food manufacturer WanaBana since October. The agency has homed in on the cinnamon specifically as …

Axios reports: Republicans on a House oversight panel will investigate the Food and Drug Administration’s handling of a common decongestant ingredient that the agency recently concluded was ineffective, the committee told Axios first. Rep. Lisa McClain (R-Mich.), chairwoman of the House Oversight subcommittee on health care and financial services, in a letter being sent today will request a briefing with …

The New York Times reports: The decision by the Food and Drug Administration on Wednesday to approve the weight loss drug tirzepatide adds a potent new tool to the fast-growing arsenal of obesity drugs. The drug, which will go by the brand name Zepbound, contains the same compound in the sought-after diabetes drug Mounjaro. Many people have used Mounjaro off-label …

The Insider reports: CVS this week said it is pulling many popular decongestants from its shelves after advisors to the Food and Drug Administration said the active ingredient simply does not work. In September, an advisory panel to the FDA ruled that phenylephrine, when taken orally, is no better than a placebo despite being on the market for more than …

The New York Times reports: The Biden administration, looking ahead to a possible winter surge of Covid-19, announced on Wednesday that it was reviving its program of offering Americans free coronavirus tests through the mail and would spend more than $600 million to buy tests from a dozen domestic manufacturers. The website for the program, covidtests.gov, will begin accepting orders …