fda
78 stories · Page 4 of 4
The FDA Approved a Better Penile Implant. For Most Men, ED Is the Heart Warning Them First.
The 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 & FDAAnother Clot Problem at Abiomed: The FDA Flags an Impella Introducer, and the Pattern Keeps Growing
FDA 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.
Infectious DiseaseXocova clears the FDA. What it actually prevents is the smaller story.
The 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 & FDAFDA's New Gene Therapy Shortcut Leans on 'Platform Knowledge.' Six Months Ago, They Revoked Sarepta's After Three Patient Deaths.
FDA's new gene therapy draft guidance invites sponsors to lean on "platform knowledge" to streamline submissions, six months after the agency revoked Sarepta's AAVrh74 platform designation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 & FDAAndrew Huberman's peptide masterclass and the published evidence
Andrew 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 & FDAHepatitis Delta Has Waited Forty-Nine Years for a Drug. The FDA Made American Patients Wait Three Extra.
The 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.