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Fda Approval

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Intellia's in-body CRISPR therapy shows lasting effect after four years

Intellia Therapeutics has released four-year follow-up data showing its gene-editing therapy lonvoguran ziclumeran continues to suppress a protein that triggers hereditary angioedema attacks. The treatment uses CRISPR-Cas9 delivered directly into the body to disable the gene producing prekallikrein, rather than editing cells outside the body as with existing therapies. Intellia has filed for FDA approval, with a decision expected by 10 March.

Samsung's Galaxy Ring gains FDA-cleared advanced sleep apnea detection

Samsung announced that its Galaxy Ring and Galaxy Watch devices received FDA approval in July for an upgraded sleep apnea detection feature. The AI-powered tool now tracks breathing disruptions hourly and can report mild, occasional or frequent apnea after users log at least five hours of sleep on two nights within a ten-day span. The feature is also rolling out to the Galaxy Watch 9, with Watch 7 and 8 support planned via future updates.

FDA moves to withdraw Amgen's Tavneos over alleged trial data manipulation

The FDA approved ChemoCentryx's vasculitis drug Tavneos in October 2021 after a narrow advisory committee vote, despite concerns that the pivotal trial's design made its benefits hard to verify. Amgen acquired ChemoCentryx a year later, and Tavneos has since generated nearly $500 million in annual sales at roughly $220,000 per patient per year. In April 2025, the FDA proposed withdrawing the drug, citing reports of serious liver injury and evidence—surfaced through an investor lawsuit—that ChemoCentryx employees may have manipulated trial data submitted to regulators.

Bemotrizinol sunscreen ingredient reaches US market after FDA clears it in June

Bemotrizinol, or BEMT, a sunscreen filter that has been sold across Europe since 1999, has finally been approved by the FDA and is now appearing in American products. The ingredient absorbs both UVA and UVB rays, causes minimal skin irritation, and was first filed for FDA review back in 2005. Australian brand Ultra Violette launched a BEMT sunscreen online in late August before it hit Sephora stores in October, and Neutrogena followed in September with two BEMT-based face sunscreens.

Bemotrizinol sunscreens debut in US stores after 25-year gap

Sunscreens formulated with bemotrizinol (BEMT), a UV filter long used in Europe and elsewhere, are now available on US store shelves. It marks the first new sunscreen active ingredient to reach American retail in more than 25 years.

FDA clears Edwards' expandable pediatric heart valve, the Autus

The FDA has approved Edwards' Autus Size-Adjustable Valve, an artificial pulmonary valve for children born with congenital heart defects. Unlike previous valves, it can be implanted small, starting at 13 millimeters, and later expanded inside the body using a balloon catheter up to 22 millimeters as the child grows, avoiding repeated replacement surgeries.

Study describes drug approach that degrades cancer kinases instead of just blocking them

Researchers led by Conery et al., writing in Nature, report a strategy for treating lung cancers driven by mutated kinase enzymes that destroys the target protein entirely rather than merely inhibiting its activity. The approach is aimed at cancers that develop resistance to existing kinase inhibitors after acquiring mutations near the drug's binding site. Twenty-eight kinase inhibitors are already FDA-approved across nine molecular lung cancer subtypes, but many patients eventually relapse due to such resistance mutations.

Study: transplanted hearts shift methylation age to match recipient

A new bioRxiv preprint analysed DNA methylation patterns in transplanted human hearts and found that, months after surgery, the tissue's biological age markers shifted to resemble the recipient's age rather than the donor's. Researchers observed this effect in both directions: young hearts placed in older bodies appeared to age faster, while older hearts in younger bodies appeared to grow biologically younger.

Eight Sleep launches smaller Pod 6 with solo option starting at $1,999

Eight Sleep released its Pod 6 smart mattress cooling/heating device with a 50% smaller footprint and a new solo size for single sleepers, priced from $1,999 for solo and $2,699 for standard sizes. The company says the new pod adjusts temperature 20% faster and has 9x more sensors than the prior generation, letting it distinguish between two sleepers or ignore a pet or child on the bed. The device launches today in more than 37 countries and is compatible with existing accessories.

Revolution Medicines wins FDA approval for pancreatic cancer drug after rejecting buyout offers

Revolution Medicines received FDA approval this week for a pancreatic cancer pill, a milestone that comes after the company fielded acquisition interest from larger pharmaceutical firms but chose to remain independent. The decision allowed it to bring the drug through regulatory approval on its own rather than as part of a larger acquirer's pipeline.

FDA Approves Daraxonrasib for Pancreatic Cancer After Trial Shows Doubled Survival

The FDA has cleared daraxonrasib, a new drug for pancreatic cancer, after a large clinical trial found patients on the treatment survived roughly twice as long as those receiving standard chemotherapy. The approval gives doctors a new option for a disease long known for poor treatment outcomes.