The Food and Drug Administration

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Sunscreen changes

For the first time in 20 years, the Food and Drug Administration approved a new sunscreen ingredient known as BEMT. Experts say it’s a safer option than many of the chemical additives currently used in the US.

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🚬 The FDA will allow Zyn nicotine pouches to be marketed as less harmful than cigarettes. Scientists generally agree the pouches are a safer option for smokers, but critics worry about their appeal to young people, Axios' Caitlin Owens first reported.

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FDA panel narrowly backs unapproved peptide drugs favored by RFK Jr. and wellness influencers

WASHINGTON (AP) — A panel of federal health advisers on Thursday narrowly recommended easing access to several peptides popular with wellness influencers and celebrities, despite warnings from government scientists that the chemicals haven’t been shown to be safe or effective.

https://apnews.com/article/peptides-fda-rfk-kennedy-bpc157-tb500-7267d0fad0110e7c2ed301d03cf5f0c2?

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FDA Eases Restrictions On Compounded Peptides Despite Safety Warnings

An advisory panel for the Food and Drug Administration (FDA) convened on July 23–24 to discuss whether seven peptides should be added to a list of drugs that compounding pharmacies are allowed to manufacture.

https://www.healthline.com/health-news/compounded-peptides-eased-restrictions-fda?

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Flu vaccines

The FDA has approved the first mRNA-based flu vaccine in the US for adults 50 and older, drugmaker Moderna announced Wednesday. Unlike traditional flu shots, which require strains to be selected months in advance, the mRNA vaccine can be updated much closer to flu season, potentially making it a better match for circulating viruses. In Moderna's study of more than 40,000 adults 50 and older, the vaccine was about 27% more effective than standard flu shots last year. If rolled out as planned, Moderna said the vaccine will be available to eligible US adults for the 2026-27 respiratory virus season, which typically begins in October.   New kind of flu shot is on the way as the FDA approves Moderna's mRNA-based vaccine The Food and Drug Administration has approved a new kind of flu vaccine for older people, the first made with the same mRNA technology that was key to ending the COVID-19 pandemic, manufacturer Moderna said. Read More.

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Faster Flu Shot

The Food and Drug Administration has approved the first mRNA flu vaccine for adults age 50 to 64, expanding a Nobel Prize-winning technology first used to combat COVID-19. Unlike traditional vaccines, which take several months to develop, mRNA vaccines can be produced in about six weeks and modified to match emerging flu strains.  Developed by Moderna, mFlusiva uses the mRNA plug-and-play model in which genetic sequences for any virus or pathogen can be swapped into the vaccine. Traditional vaccines require growing virus components, which limits the possibility of quick adaptation. The new vaccine coming this fall is 27% more effective than a standard flu shot, though clinical trial participants reported mild side effects like injection-site pain, fatigue, and headaches. Influenza ranks as the 11th leading cause of death in the US, and it results in over 300,000 deaths worldwide annually. Flu season typically runs from October to May in the US. Explore a map tracking reported cases of influenza-like illness here.

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New kind of flu shot is on the way as the FDA approves Moderna’s mRNA-based vaccine

WASHINGTON (AP) — The Food and Drug Administration has approved a new kind of flu vaccine for older people, the first made with the same mRNA technology that was key to ending the COVID-19 pandemic, manufacturer Moderna said.

https://apnews.com/article/flu-vaccine-moderna-mrna-fda-mflusiva-59d991a6bf70c26e2f0c210cc8ca87f1?

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FDA OKs groundbreaking cancer drug

Illustration: Maura Kearns/Axios The FDA approved a groundbreaking new drug for the most common form of pancreatic cancer, offering patients a more effective treatment against one of the deadliest types of cancer. 💊 The first-of-a-kind pill, called daraxonrasib, blocks a mutated protein that fuels tumor growth in more than 90% of pancreatic cancer cases. The daily pill will be sold by Revolution Medicines under the brand name Rasonque. Patients taking the drug nearly doubled their survival time, with fewer severe side effects, in a study that randomly assigned them to receive the experimental treatment or additional chemotherapy. The treatment hit the spotlight earlier this year when former Sen. Ben Sasse (R-Neb.) described his positive experience with it on "60 Minutes." 🩻 Pancreatic cancer is one of the deadliest cancers, in large part because it's often not detected until it's spread. The American Cancer Society estimates that about 67,000 new cases will be diagnosed in the U.S. this year, while more than 52,000 people will die from the disease. Dr. Pashtoon Kasi of City of Hope Orange County, a California-based cancer center, tells AP: "This is not a cure, it's one more option for these patients." "But it's the best option we've ever had." Go deeper.

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FDA approves updated Covid-19 vaccines

Vaccines from Moderna, Novavax and Pfizer/BioNTech received federal approval this week. (Joseph Prezioso/AFP/Getty Images)

The FDA has signed off on updated Covid-19 vaccines for all adults 65 and older, as well as certain younger people at higher risk of severe illness. While the CDC has yet to make an official recommendation for this year’s vaccines, most medical organizations recommend getting one because the shots target circulating variants as protection from previous doses wanes. Covid cases remain relatively low, but CDC data shows test positivity nearing 5% for the first time since February, with rates climbing in every state. The updated vaccines should begin arriving at pharmacies and doctors’ offices in September.

+ Read more: FDA approves updated Covid-19 vaccines for many Americans

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💊 FDA's bid to beat China

Illustration: Annelise Capossela/Axios

The FDA is launching a pilot program intended to speed up how new drug candidates move from discovery into human clinical trials, Axios' Caitlin Owens writes. Why it matters: Early-stage drug development in China is cheaper and faster than in the U.S. The pilot envisions partnering drug companies with qualified research institutions that will help them submit new drug applications to the agency.

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Cancer Detection Test

A Food and Drug Administration advisory panel voted yesterday to endorse a blood test designed to detect up to 50 forms of cancer in people aged 50 or older. The decision suggests full FDA approval may be forthcoming, opening the door to Medicare and private insurance coverage.  The DNA-based Galleri test uses a single blood draw to assess if a user may have tumors caused by cancers missed by current screenings, like ovarian and thyroid cancers. FDA panelists noted that one-third to one-half of the test’s positive results may be false but concluded its benefits outweighed the risks. There is no large-scale randomized data finding Galleri reduces cancer mortality. Biotech company Grail states the test should be used to complement existing screenings, not replace them. It retails for $949 online. Cancer is the second-leading cause of death in the US behind heart disease. See a breakdown of 2026 case numbers and demographics here.

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FDA nominee says vaccines are safe despite Trump efforts to overhaul childhood shots

WASHINGTON (AP) — President Donald Trump’s pick to lead the Food and Drug Administration voiced support for the safety of long-established vaccines at a hearing Thursday, even as senators questioned her about the White House’s efforts to upend childhood immunizations.

https://apnews.com/article/fda-heidi-overton-abortion-vaccines-trump-fd4ddb8923d3c2653e0c89e73cc2ac02?

FDA panel endorses first-of-a-kind cancer blood test from Grail

WASHINGTON (AP) — Federal health advisers on Wednesday endorsed a blood test designed to spot signs of various cancers in apparently healthy people while warning that it’s far from clear how well the technology works.

https://apnews.com/article/grail-test-cancer-fda-dna-8fc5480be365b59c450043daa38cad30?