All posts tagged: FDA

FDA approves first mRNA flu vaccine. Here’s what it could mean for future medicines

FDA approves first mRNA flu vaccine. Here’s what it could mean for future medicines

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 Vaccines have been reliably and affordably protecting people from diseases worldwide for centuries. Until the COVID-19 pandemic, however, vaccine development was still a long and idiosyncratic process. Traditionally, researchers had to tailor manufacturing processes and facilities for each vaccine candidate, and the scientific knowledge gained from one vaccine was often not directly transferable to another. But the COVID-19 mRNA vaccines brought a new approach to vaccine development. And on Aug. 5, 2026, the U.S. Food and Drug Administration approved another mRNA vaccine – a seasonal flu vaccine for adults age 50 or older – that offers more protection against influenza compared to standard vaccines. These advances demonstrate the momentum of mRNA technology, and they have far-reaching implications for how researchers make drugs to treat many other diseases. Vaccines have been reliably and affordably protecting people from diseases worldwide for centuries (AFP …

How the FDA is tackling PFAS in food

How the FDA is tackling PFAS in food

Published by skeptic

PFAS in food has become one of the most closely watched food safety challenges in the United States. As scientific understanding of these persistent “forever chemicals” has evolved, regulators have shifted from asking whether PFAS are present in the food supply to determining where they occur, how consumers are exposed and what actions are needed to reduce risks. For the United States Food and Drug Administration (FDA), addressing PFAS in food has required a combination of scientific research, targeted surveillance, regulatory action and collaboration with federal agencies, state governments and industry. Rather than relying on a single policy, the agency has developed an increasingly comprehensive strategy that combines improved laboratory testing, food monitoring, packaging reform and risk assessment. Although the FDA maintains that the vast majority of foods sold in the US remain safe to eat, investigations over the past several years have demonstrated that PFAS contamination can occur in certain foods, particularly seafood and products produced in areas affected by environmental pollution. These findings have transformed PFAS from an emerging contaminant into a major …

FDA nears a decision on Moderna mRNA flu vaccine : NPR

FDA nears a decision on Moderna mRNA flu vaccine : NPR

Published by Sam Flores

Moderna will soon learn the regulatory fate of its mRNA-based flu shot. Maddie Meyer/Getty Images hide caption toggle caption Maddie Meyer/Getty Images For the latest stories on the science of healthy living, subscribe to NPR’s Health newsletter.  Health Secretary Robert F Kennedy Jr. has long questioned the value of mRNA vaccine technology. And soon the Food and Drug Administration will decide whether to approve a new kind of flu shot built on mRNA. How the agency rules on the experimental vaccine made by Moderna has big implications for the future of mRNA research. In February, Moderna president Stephen Hoge was at one of the company’s manufacturing sites, when the head of regulatory affairs, Charbel Haber, approached him. Almost immediately Hoge knew something was wrong. “Charbel came up to me and just had a very nervous look on his face,” he says. “And when your head of regulatory comes up and has a concerned look on … [his] face, you take it seriously.” Moderna had just gotten a letter from the FDA. Hoge rushed with Haber to …

FDA Panel Backs Wider Access To Six Peptide Therapies, Citing Grey Market Concerns

FDA Panel Backs Wider Access To Six Peptide Therapies, Citing Grey Market Concerns

Published by Jenni Sidey

Via American Greatness, A Food and Drug Administration (FDA) advisory panel has voted to recommend expanding legal access to six popular peptide compounds. Supporters say it could pull patients out of the unregulated grey market that has flourished under years of federal inaction. The FDA’s Pharmacy Compounding Advisory Committee reviewed seven peptides during a two-day hearing in Maryland last week, weighing whether each should be added to the agency’s Section 503A Bulks List. Reuters reported the panel voted in favor of moving six forward: BPC-157 for ulcerative colitis, TB-500 and KPV for wound healing, MOTS-c for obesity and osteoporosis, Semax for cerebral ischemia, migraine and trigeminal neuralgia, and Epitalon for insomnia. Peptides are short chains of amino acids that help regulate metabolism, growth and tissue repair, according to the Cleveland Clinic. Some, including insulin and GLP-1 weight loss drugs, are already FDA approved, while others have remained in regulatory limbo even as demand exploded among patients seeking help with weight loss, muscle building, chronic disease and performance. If the FDA ultimately adopts the recommendation, licensed …

7-OH Users Are Stockpiling and Doing Reddit Detoxes to Prep for Ban

7-OH Users Are Stockpiling and Doing Reddit Detoxes to Prep for Ban

Published by skeptic

A couple months after completing detox for alcohol in June 2023, Cam got into a brutal motorcycle accident. The 36-year-old upstate New York resident woke up hospitalized in late September after a month in a coma. “I broke every rib, every vertebrae. My pelvis was completely shattered,” says Cam, who asked to be identified by his first name because he is discussing drug use. He needed a spinal fusion and was unable to return to his job in car parts manufacturing. “I was in pain 24/7,” Cam says. He needed serious painkillers, and he says the 15 milligrams of oxycodone a day he was prescribed wasn’t cutting it. “I didn’t sleep for months. I would literally scream in agony, like crying, screaming uncontrollably,” he says. (Dosing for opioids can vary greatly depending on a person’s tolerance and pain level, but 15 mg is not considered a high dose—and Cam notes he used to take “20 times that” when he struggled with addiction in the past.) In early 2024, he says he was served an Instagram …

An FDA Panel Just Endorsed These Unproven Peptides

An FDA Panel Just Endorsed These Unproven Peptides

Published by skeptic

Peptides are inching closer to the mainstream. A panel of experts on Thursday narrowly recommended that the Food and Drug Administration reclassify four popular peptides—including one endorsed by podcaster Joe Rogan—to allow certain pharmacies to legally dispense them. In an at-times emotionally charged meeting that lasted more than 11 hours, members of an FDA advisory committee heard data presentations from FDA staff on four unapproved peptides—BPC-157, KPV, TB-500, and MOTs-C—as well as testimony from health care practitioners, patients, pharmacies, and clinics. Members voted eight to six, with one abstention, to add three of the four peptides to the agency’s bulks list, meaning compounding pharmacies can use them to create custom medications for patients. (The fourth peptide—MOTs-C—received a seven-to-five vote in favor, with two abstentions.) The advisory panel, which includes several members tied to peptide-related businesses and telehealth clinics, will consider three more peptides on Friday. Peptide therapies have been growing in popularity thanks to the endorsement of podcasters, wellness influencers, and Health and Human Services Secretary Robert F. Kennedy Jr., who has said he’s a …

FDA panel to consider easing restrictions on peptide production : NPR

FDA panel to consider easing restrictions on peptide production : NPR

Published by Sam Flores

In this image taken from video, an IV infusion is administered at Pure Alchemy Wellness in Chula Vista, Calif., in November 2025. Javier Arciga/AP hide caption toggle caption Javier Arciga/AP Stay up to date with our Up First newsletter, sent every weekday morning. It’s a big week for the peptide industry and the growing number of Americans who’ve come to embrace the therapies touted for wellness and longevity. The Food and Drug Administration is convening a panel of outside experts for a two-day meeting starting Thursday to make recommendations on whether compounding pharmacies should be allowed to make some of the most popular injectable peptides. The gathering of the Pharmacy Compounding Advisory Committee is slated to begin early Thursday morning and stretch until Friday afternoon. The group will review the evidence for seven compounds, including some of the most sought-after injectables: TB-500, BPC-157 and MOTs-C. None of them has undergone the kind of large-scale trials to establish safety and effectiveness that are required for FDA drug approvals. “I see it as very risky,” says Paul …

Taylor Farms Spent Big on MAGA and Anti-Regulatory Lobbying Before Diarrhea Outbreak

Taylor Farms Spent Big on MAGA and Anti-Regulatory Lobbying Before Diarrhea Outbreak

Published by skeptic

The lettuce supplier at the center of the turbo diarrhea outbreak has spent millions of dollars to sway sentiment around food regulation and elect Donald Trump and other MAGA Republicans, according to public filings. Taylor Farms donated more than $2 million to conservative political groups in 2025, according to Federal Election Commission filings. That includes a $1 million donation to MAGA Inc., the Trump-centric super PAC, and $1.1 million to other super PACs dedicated to electing Republicans. From 2020 through the end of 2024, the company donated more than $1.6 million to conservative PACs, including a total of $850,000 to AFP Action, an anti-regulation super PAC with ties to the Koch network. Bruce Taylor, the chairman and CEO of Taylor Farms, is also a longtime donor to Republican causes. Since 2020, Taylor has personally donated more than $900,000 to Republican PACs and candidates, including contributions to Texas senator John Cornyn and Tennessee senator Marsha Blackburn. Like many corporate giants, Taylor Farms has also spent big on lobbying related to industry regulation. In early 2025, it …

The Great Peptide Cash Grab Has Begun

The Great Peptide Cash Grab Has Begun

Published by skeptic

Has anyone tried to sell you peptides yet? If not, they probably will soon. Once a niche interest among bodybuilders and biohackers, peptides are an increasingly popular class of substance hyped by both fringe influencers and the current US Secretary of Health and Human Services. Earlier this year, Robert F. Kennedy Jr. told the podcaster Joe Rogan that the government intended to loosen restrictions on peptide production. This week, it could finally happen: On July 23 and 24, the Food and Drug Administration will discuss whether to reclassify a group of peptides so that pharmacies can legally make custom mixes, a process known as compounding. The move would reverse a decision made in 2023 by the Biden Administration, which barred certain peptides from being compounded. Although career scientists at the agency have recommended against it, many industry insiders tell WIRED they believe the FDA will approve reclassification anyway, since the committee put together to do the assessment includes peptide boosters. Some players in the telehealth world are already operating under the assumption that the floodgates …