“The company hasn’t yet shown that its drug actually extends lifespan, but the FDA decision signals the agency’s confidence in Loyal’s approach, and the drug will soon be tested in a bigger trial.” ~ learn more
A bit of publicity almost killed this startup, Bobbie, by drawing the attention of regulators to their pilot. This is the story of how they turned the situation around and capitalized on the moment. A couple years since this article […]
From Alex Tabarrok in Marginal Revolution: “The FDA has a long history of antipathy towards personal testing. The FDA has opposed personal pregnancy tests, HIV tests, genetic tests, and COVID tests, as I discussed in my article Testing Freedom. Well, […]
This is mostly about a category of products called relaxers. They are used by women to straighten their hair. The author notes that they seem safe because they’re sold in stores, but they are not regulated by the FDA and […]
Semaglutides came on the scene after last year’s FDA approval. “Until now, doctors didn’t really use medication to treat obesity; the drugs either didn’t work or had too many side effects. … Semaglutide marks the start of a new generation of […]
“Deregulated device types show increases in entry, innovation, as measured by patents and patent quality, and decreases in prices. Safety is either negligibly affected or, in the case of products that come under potential litigation, increased.” | learn more
Little FDA enforcement and bold claims make for a problematic pair. “Although stem cells for some conditions promoted by the clinics Turner studied have produced promising results in early-phase studies, they generally haven’t been shown to be safe and effective […]
“Fitbit is currently working with the US Food and Drug Administration (FDA) for market authorization to allow the algorithm to be widely deployed.” | learn more
Don’t let the big words scare you off. This is an insightful analysis of the FDA’s recent approval of a new Alzheimers drug from Scott Alexander. Conclusion: unbundle the FDA! | learn more
The approval came despite the advisory committee’s near-unanimous vote against it. “The approval, however, will do little to quell criticisms from the swath of Alzheimer’s researchers, biostatisticians, and clinicians who have argued that Biogen cherry-picked data and failed to show […]