11 stories
A Pentagon-funded fentanyl vaccine licensed to startup ARMR Sciences will begin Phase 1 in the Netherlands in early 2026. Three decades of failed addiction vaccines, and a supply chain that runs through Chinese precursor labs, are the context the press release leaves out.
Drugs & FDAScripps Research published a clever chemistry redesign that let mice's immune systems recognize an entire class of fentanyl analogues. The headlines called it an overdose blocker. The mice are doing fine. Humans are years away, and the overdose decline is already happening without it.
Drugs & FDAThe Trump administration on Thursday proposed closing the product-hopping loophole that lets drugmakers reset Medicare's negotiation clock by tweaking inactive ingredients. It is the same fix the same administration quietly tabled in October.
Drugs & FDAA 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Drugs & FDAThe FDA's new draft guidance lets oncology developers cut animal studies for certain biologics and conjugated products.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.
Drugs & FDAAlnylam paid Inceptive Nucleics $30 million up front, with up to $2 billion in milestones tied to outcomes the rest of AI drug discovery has spent a decade failing to deliver.
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Drugs & FDAFDA's new gene therapy draft guidance invites sponsors to lean on "platform knowledge" to streamline submissions, six months after the agency revoked Sarepta's AAVrh74 platform designation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.
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.