Tag Archives: FDA

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 …

The Associated Press reports: The leading decongestant used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient. Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the ingredient found in …

Via press release from the FDA: Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and …

Changing America reports: Is it safe to use a COVID-19 test that is past the expiration? The answer, it turns out, depends on what brand of test you have. The FDA has extended that date for a number of different at-home COVID-19 tests. The expiration date for multiple lots of BinaxNow COVID-19 antigen tests that were sold at CVS, for …

The New York Times reports: The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription for the first time in the United States, a milestone that could significantly expand access to contraception. The medication, called Opill, will become the most effective birth control method available over the counter — more effective at …

NBC News reports: An influencer-backed energy drink that has earned viral popularity among children is facing scrutiny from lawmakers and health experts over its potentially dangerous levels of caffeine. On Sunday, Sen. Charles Schumer called on the Food and Drug Administration to investigate PRIME, a beverage brand founded by the YouTube stars Logan Paul and KSI that has become something …

NPR reports: The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer’s disease. The action means that Leqembi, whose generic name is lecanemab, should be widely covered by the federal Medicare health insurance program, which primarily serves adults age 65 and older. So more people who are in the early stages of the disease …

Axios reports: Federal regulators are laying out guidance for psychedelic drug trials for the first time, in a move that could encourage the mainstreaming of substances like magic mushrooms and LSD as behavioral health treatments. Psychedelics are turning into a multi-billion industry and gaining widespread acceptance after decades of concerns about recreational use of the products — and the high …

NBC News reports: Advisers to the Food and Drug Administration on Thursday recommended updating the Covid vaccines to target a circulating strain of the virus, while pushing for newer vaccines that provide longer-lasting protection. The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously in support of tweaking the shots to target an XBB strain, as well as dropping …

Via press release from the FDA: A single mistake can prove fatal. We continue to receive reports of people dying or being severely injured after consuming poppers that resemble, and often mistaken for, popular energy shots. Drinking or inhaling poppers seriously jeopardizes your health. Health care providers are reporting increases in deaths and hospitalizations related to intentional ingestion or inhalation …

The Associated Press reports: Gay and bisexual men in monogamous relationships can donate blood in the U.S. without abstaining from sex, under a federal policy finalized Thursday by health regulators. The Food and Drug Administration guidelines ease decades-old restrictions designed to protect the blood supply from HIV. The agency announced plans for the change in January and said this week …

The New York Times reports: A panel of advisers to the Food and Drug Administration voted unanimously on Wednesday that the benefits of making a birth control pill available without a prescription outweigh the risks, a significant step in the decades-long push to make oral contraception obtainable over the counter in the United States. If the F.D.A. approves nonprescription sales …

CBS News reports: Do you like taking your dog to restaurants? Go ahead, it’s fine, according to the Food and Drug Administration which now says it’s safe to bring dogs to restaurants with outdoor seating. The new guidance came in an update to the 2022 FDA food code. The FDA stated that its health rules “allow for pet dogs in …

Gothamist reports: Consumer Reports is pushing for the removal of Red Dye No. 3 from multiple Peeps candies — saying the ingredient is a carcinogen — days ahead of Easter and peak Peep season. Several Peeps products — including Pink Marshmallow Chicks, Easter Marshmallow Pink Bunnies and Easter Marshmallow — contain the ingredient, which has been debated for decades over …

The New York Times reports: Narcan, a prescription nasal spray that reverses opioid overdoses, can now be sold over the counter, the Food and Drug Administration said on Wednesday, authorizing a move long-sought by public health officials and treatment experts, who hope wider availability of the medicine will reduce the nation’s alarmingly high drug fatality rates. By late summer, over-the-counter …

Reuters reports: On at least four occasions since 2019, Elon Musk has predicted that his medical device company, Neuralink, would soon start human trials of a revolutionary brain implant to treat intractable conditions such as paralysis and blindness. Yet the company, founded in 2016, didn’t seek permission from the FDA until early 2022 – and the agency rejected the application, seven current …

Via press release: Today, the U.S. Food and Drug Administration announced that it has taken action to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country to address a growing public health concern. The chemical xylazine has increasingly been found in illicit drugs such as illicitly manufactured fentanyl and other drugs …

CBS News reports: Some of the biggest makers of cereals, frozen and packaged food have submitted dozens of claims to the Food and Drug Administration objecting to new rules that would exclude food with high amounts of added sugar and salt from being labeled as “healthy” on packaging. Some manufacturers have even called the regulations unconstitutional, saying they violate companies’ …

Via press release from the FDA: Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test …

The Associated Press reports: Soy, oat, almond and other drinks that bill themselves as “milk” can keep using the name, according to draft federal rules released Wednesday. Food and Drug Administration officials issued guidance that says plant-based beverages don’t pretend to be from dairy animals – and that U.S. consumers aren’t confused by the difference. Dairy producers for years have …