All posts tagged: FDA

FDA fast-tracks review of three psychedelic drugs after Trump order

FDA fast-tracks review of three psychedelic drugs after Trump order

Published by Daniella Wilson

Get the Well Enough newsletter with Harry Bullmore for tips on living a healthier, happier and longer life Get the Well Enough email with Harry Bullmore Get the Well Enough email with Harry Bullmore The FDA has announced an “ultra-fast” review of three psychedelic drugs aimed at treating mental health conditions including depression, signaling a significant commitment from the Trump administration to this experimental therapeutic approach. President Donald Trump signed an executive order last weekend directing the FDA and other federal agencies to accelerate access and ease restrictions on psychedelics, a class of hallucinogenic drugs that remain illegal under federal law. The FDA confirmed it has awarded priority review vouchers to two companies researching psilocybin – the active ingredient in magic mushrooms – for difficult-to-treat forms of depression. A third company received a voucher for methylone, a drug related to MDMA, for post-traumatic stress disorder. The FDA did not disclose the names of these companies in its press release. While these vouchers do not guarantee approval, they indicate that regulators will aim to shorten their …

FDA approves first gene therapy for genetic hearing loss

FDA approves first gene therapy for genetic hearing loss

Published by Sam Flores

The Food and Drug Administration on Thursday approved Regeneron’s Otarmeni, the first gene therapy for genetic hearing loss. Subscribe to read this story ad-free Get unlimited access to ad-free articles and exclusive content. The drugmaker said it will offer the drug for free to U.S. patients. Otarmeni is approved to treat a very rare form of hearing loss that affects about 50 babies born in the U.S. each year and is caused by a mutation in a gene called OTOF. The approval was granted under the Commissioner’s National Priority Voucher, an FDA pilot program intended to fast-track drug reviews. “This really is life-changing for families with children with hearing loss,” Dr. Eliot Shearer, a pediatric otolaryngologist at Boston Children’s Hospital and a principal investigator on the Regeneron trial. The only other treatment option for children with genetic deafness is cochlear implants, Shearer said, which restore the ability to hear speech and music, but reduce the fidelity of the sound. With gene therapy, the improved hearing is “on 24/7 and doesn’t rely on batteries,” he added. …

Why Is the New York Times Laundering the Reputation of a Sleazy AI Startup That’s Selling GLP-1s via a Dishonest Dumpster Fire of Fake Doctors, Phony Before-and-After Pictures, a Warning From the FDA, and Other Glaring Red Flags?

Why Is the New York Times Laundering the Reputation of a Sleazy AI Startup That’s Selling GLP-1s via a Dishonest Dumpster Fire of Fake Doctors, Phony Before-and-After Pictures, a Warning From the FDA, and Other Glaring Red Flags?

Published by José Betancourt

Sign up to see the future, today Can’t-miss innovations from the bleeding edge of science and tech On Thursday, the New York Times published a glowing profile of a company called Medvi. The basic premise of the piece is that a single guy named Matthew Gallagher had used AI to rapidly build a pharmaceutical enterprise that’s on track to do nearly $2 billion in sales this year, while hiring only a skeleton crew of humans to operate the vast AI-powered venture. According to the NYT, it’s a stunning achievement that heralds a new era of business; OpenAI CEO Sam Altman, who predicted the rise of this kind of company back in 2024, told the newspaper that he’d “like to meet the guy” behind the project. “A $1.8 billion company with just two employees?” the NYT rhapsodized. “In the age of AI, it’s increasingly possible.” The NYT‘s tech coverage is generally pretty solid. But the framing of its story, and what it left out, left us pretty stunned. That’s because back in May of last year, we ran …

Cheese products recalled ‘under protest’ as FDA investigates E coli outbreak

Cheese products recalled ‘under protest’ as FDA investigates E coli outbreak

Published by Daniella Wilson

Get the Well Enough newsletter with Harry Bullmore for tips on living a healthier, happier and longer life Get the Well Enough email with Harry Bullmore Get the Well Enough email with Harry Bullmore A California dairy producer is recalling some of its raw cheese products as health authorities investigate an ongoing outbreak of E. coli. Raw Farm of Fresno, California, said Thursday it is voluntarily recalling more than a half-dozen varieties of its cheddar cheese made from raw milk. The recalled batches, pictured on the FDA recall notice, carry expiration dates spanning from May 2026 to September 2026. They were sold nationwide, according to the FDA alert. The company announced the recall after health authorities launched an investigation into an ongoing outbreak of E. coli, which was first announced on March 15. Interest in and sales of raw milk have been rising in recent years, fueled by social media and growing support from the Health Secretary Robert F. Kennedy Jr.’s Make America Healthy Again movement. Raw milk has not been pasteurized, which kills germs …

New Foundayo weight loss pill approved by FDA

New Foundayo weight loss pill approved by FDA

Published by Daniella Wilson

Get the Well Enough newsletter with Harry Bullmore for tips on living a healthier, happier and longer life Get the Well Enough email with Harry Bullmore Get the Well Enough email with Harry Bullmore Federal regulators have approved Eli Lilly’s new weight-loss pill, a second daily oral medication to treat obesity and other weight-related conditions. The FDA granted expedited approval to orforglipron, a GLP-1 drug that works like widely used injectable medications to mimic a natural hormone that controls appetite and feelings of fullness. The drug, which will be branded as Foundayo, is expected to begin shipping Monday. The company said people with insurance may be able to get the drug starting at $25 per month with a Lilly discount card. Prices for people paying cash will range between $149 per month to $349 per month, depending on the dose. The new pill joins drugmaker Novo Nordisk’s oral Wegovy pill, which has spurred more than 600,000 prescriptions in the United States since it was approved in December. Both the Lilly and Novo Nordisk pills resulted …

FDA Approves Eli Lilly’s GLP-1 Pill

FDA Approves Eli Lilly’s GLP-1 Pill

Published by skeptic

The US Food and Drug Administration on Wednesday approved a new obesity pill called Foundayo. Taken once daily, the pill is made by pharmaceutical company Eli Lilly, which also manufactures the popular weight-loss injection Zepbound. Foundayo is a type of medication known as a GLP-1, a category that includes rivals Ozempic and Wegovy. These drugs mimic a naturally occurring hormone in the body that regulates blood sugar, slows digestion, and signals a sense of fullness to the brain. It’s now the second GLP-1 pill for weight loss on the market. In December, Novo Nordisk received FDA approval for its pill form of Wegovy. The company’s original version of Wegovy is a weekly injectable. While the Wegovy pill must be taken on an empty stomach in the morning, Lilly says Foundayo can be taken any time of day without food or water restrictions. With injectable GLP-1 drugs in high demand, pharma companies have been racing to develop weight-loss pills, which could be preferable for some patients and could potentially expand the market for GLP-1s. Pills are …

How to stay away from PFAS

How to stay away from PFAS

Published by Jenni Sidey

Get the Popular Science daily newsletter💡 Breakthroughs, discoveries, and DIY tips sent six days a week. Per- and polyfluoroalkyl substances, also known as PFAS, are a group of 9,000 different man-made chemicals—all of them with equally unpronounceable and complicated names. But navigating this tongue-twister is the least of our concerns: PFAS are toxic and they’re everywhere.  Biochemists have found them in the bodies of 97 percent of Americans, as well as in breast milk, and researchers believe exposure to these compounds may be associated with multiple health problems, such as immune system disruption, developmental issues, impaired fertility, liver damage, and various kinds of cancer. Most of the PFAS that make it into our bodies do it through drinking water, but because there’s not one single source of exposure, you can still curb some of these chemicals in your everyday life. No, but seriously, what exactly are PFAS? PFAS came to notoriety in the 1940s, when manufacturers started using them in products such as non-stick cookware, stain-resistant fabrics, and water-repellent clothing. These days, you can also …

Best LED Masks of 2026, Cleared by the FDA

Best LED Masks of 2026, Cleared by the FDA

Published by skeptic

Jessica Rendall/CNET LED masks, which have light-emitting diode in the form of red, near-infrared and blue light, are still making wellness waves as one of the trendiest (and priciest) ways to revamp your skincare routine at home, using a powered-down approach to anti-aging and skin rejuvenation already done at the dermatologist’s office. However, this doesn’t mean all LED face masks are created equal. In fact, many of them do not have the right specifications or safety clearance to improve your skin’s glow or reduce the appearance of acne.  Before you get started with light therapy at home, it’s important to note that an LED face mask shouldn’t replace an existing skincare routine consisting of research-backed ways to keep your skin healthy and glowing, including using a sunscreen with SPF 30 or over, finding a face-washing cadence that suits your skin type and regularly using other skin-boosting agents, such as retinoids.  It’s also important to keep in mind that even the best LED face masks will not work skin miracles or cause your face to change …