9 stories tagged "fda"
A new chemical UV filter Europe approved in 1999 just cleared the FDA after a 21-year wait, while Americans relied on ingredients the agency's own 2019 review could not call safe.
Drugs & FDAThe FDA's new draft guidance lets oncology developers cut animal studies for certain biologics and conjugated products. The replacement laboratory methods are still being validated.
CancerRevolution Medicines' daraxonrasib nearly doubled median overall survival versus chemotherapy in previously treated metastatic pancreatic cancer at ASCO 2026, with 8.5 months of follow-up and a two-billion-dollar Royalty Pharma deal already riding on what comes next.
Drugs & FDAFDA flags Abiomed's 14Fr Low Profile Introducer Kit after a higher than expected complaint rate of clots forming on the device during prolonged Impella CP support. Three serious injuries reported, no deaths. The pattern keeps growing.
Drugs & FDAThe FDA approved Coloplast's Titan Prime inflatable penile prosthesis on June 3, 2026. For the men whose vasculature is past saving, it is a meaningful device upgrade. For most men with new ED, the more useful conversation is what the small arteries are failing to do years before the coronaries noti
Drugs & FDAAndrew Huberman's June 1 episode on peptides walks through BPC-157 and seven other compounds. The published human evidence for its lead substance runs to fewer than thirty people.
Drugs & FDAFDA's new gene therapy draft guidance invites sponsors to lean on "platform knowledge" to streamline submissions, six months after the agency revoked Sarepta's AAVrh74 platform designation following three patient deaths.
Infectious DiseaseThe FDA approved Shionogi's ensitrelvir for post-exposure COVID prevention, citing a 67% relative risk reduction. Look at what the trial actually measured and a different story comes into focus.
Drugs & FDAThe FDA cleared bulevirtide for chronic hepatitis delta this week, six years after Europe started using it and three years after a U.S. application was turned down on manufacturing grounds. The wait is its own story.