fda
Every record this desk has filed under fda, newest first, each with the number of sources it can still show you.
FDA approves the first treatment for Sanfilippo syndrome type A. The evidence used a historical comparison group.
Fayuvi's September 17 approval gives families a new treatment option. The study design and safety warnings matter alongside that milestone.
Also filed undergene-therapypublic-health
FDA opened applications for a pilot meant to shorten the road to a first-in-human drug trial. Eight to ten pairs get in, the window closes October 30, and the agency keeps every power it had.
On September 15 the FDA announced the final design of its Expedited Investigational New Drug Pilot and began accepting applications. Drug sponsors apply paired with a qualified research institution; the FDA will review and accept individual components of an IND application on a rolling basis during the pre-IND phase rather than waiting for the whole package, with the aim of finding problems early enough to avoid a clinical hold during the 30-day IND period. The agency says first-in-human trials 'may take up to two years to complete in the United States' and are finished faster in China and Australia. Applications close October 30, 2026; the FDA expects 8-10 sponsor-institution pairs in the first cohort, and states it retains full regulatory authority throughout, including whether a trial may proceed.
Also filed underclinical-trialsdrug-developmentdeadlinehealth
Four things to check at home this week: two sunscreen ingredients FDA just ruled out, a 2.3-million-bottle candy recall, fire-spray canisters that can rupture, and a cheese with undeclared egg.
On September 11 the FDA published a final order removing PABA and trolamine salicylate as sunscreen active ingredients, finding that a sunscreen containing either is not generally recognized as safe and effective. The day before, the Consumer Product Safety Commission announced two recalls a household can check in seconds: about 2.3 million Ricky Joy Sour Crush rolling liquid candy bottles, whose rolling ball can detach and choke a child, and about 31,000 Hero Fire Spray canisters, which can deteriorate and rupture — the firm has nine reports of canisters exploding or deteriorating in storage. And Whole Foods Market is recalling Cabricharme cheese sold at 18 stores because it contains an egg protein not declared on the label. What each notice asks you to look for, and what none of them says.
Also filed undercpscrecallsconsumer-safetysunscreenfood-safetyallergens
Two recalls this week come down to a number you can check at home: one UPC on a bag of broccoli sprouts, and six lot codes on wellness vials.
A Salmonella outbreak linked to sprouts has made 22 people sick in Idaho, Montana, Utah and Washington, two of them hospitalized, and Evergreen Fresh Sprouts, LLC is recalling 215 cases of broccoli sprouts carrying UPC 8 38796 00105 1 and five Use By dates from 9/07/26 to 9/16/26. Separately, Houston's Centric Compounding is recalling six lots of injectable Glutathione, Myer’s Cocktail and Tri-Immune Boost vials — shipped nationwide, including straight to patients' homes — after finding they were compounded with a Glutathione ingredient containing elevated endotoxin levels; the company has received nine reports of reactions. Both notices are company announcements posted by the FDA, and both ask for the same thing: match the code, and throw it out.
Also filed underrecallsfood-safetysalmonellacompoundingpublic-health
A record appears here because it carries fda in its own frontmatter. If a record you expected is missing, it was filed under a different subject — the full list is on the topics index.