Drugs & FDA
70 stories · Page 3 of 3
The Standard Treatment for Nerve Damage Was Never Built to Repair a Nerve
Gabapentin is the seventh most prescribed drug in America, handed out for neuropathy it was never shown to reverse. A retired researcher's drug-free protocol asks the question the pharmacy aisle can't: what if you removed the cause instead?
Drugs & FDAThe FDA's Fix for a $10 Billion Flood of Chinese Vapes Is a Form the Smugglers Will Ignore
Foreign manufacturers ship most of America's vapes and falsify the customs forms to do it. Washington's answer is to ask them to register with the agency they already evade.
Drugs & FDAThe FDA Pulled Infigratinib as a Cancer Drug in 2024. It Just Passed Phase 3 in Children With Dwarfism.
The FDA pulled infigratinib as a failed cancer drug in 2024. Now its maker says the same pill grows children with dwarfism faster, on a surrogate no one has yet shown reaches adulthood.
Drugs & FDAThe Immune System's Guardrails Were Too Rare to Study. A Bonn Lab Just Grew Them in a Dish.
A German lab built a way to grow follicular regulatory T cells from precursors in a dish, opening a notoriously hard-to-study brake on antibody production to direct experiment.
Drugs & FDAThe $200K Pediatric Diabetes Shot Just Won a Bigger Label. The Number That Won Isn't the One Families Will Ever See.
The FDA gave Tzield an accelerated nod for kids 8 to 17 newly diagnosed with Stage 3 type 1 diabetes. The C-peptide number won. The endpoints families would actually feel did not.
Drugs & FDAModerna's mRNA flu shot got a 9-0 vote. The comparator question that killed its first filing did not go away.
An FDA panel voted 9-0 to back Moderna's first mRNA flu vaccine. Four months earlier, the same agency refused to even read the file over the comparator the trial used. The comparator did not change.
Drugs & FDAA $200 Flu Pill Just Got a Cheaper Twin. The 10 Percent Resistance Problem Came With It.
The FDA cleared the first generic of baloxavir, the one-pill flu drug, in time for the 2026–2027 season. Cheaper is real. The mutation that turns the drug into a sugar pill is real too.
Drugs & FDAThe FDA Just Approved a Third Over-the-Counter Naloxone. The Maker Once Doubled the Price of the Injectable.
The agency calls Rextovy's OTC approval a win for access. The manufacturer's pricing history, and the market it just walked into, complicate the story.
Drugs & FDAA heart-attack drug just regrew kidney tissue in mice, and the receipts have no pharma on them
A UCLA monoclonal antibody designed to help hearts heal after a heart attack also repaired injured kidneys in mice, and it was developed without a dollar of pharma money.
Drugs & FDATestosterone Prescriptions Quadrupled. The Workups Didn't.
A Michigan Medicine chart review presented at ENDO 2026 found that only 12 percent of men prescribed testosterone got the guideline-required workup, even as the U.S. wrote 11 million testosterone prescriptions in 2024.
Drugs & FDAAstellas Brings Real-World Numbers for Its Menopause Drug to ENDO 2026. The Black Box Warning Stayed Home.
Astellas presented its first real-world numbers for Veozah at ENDO 2026, framed as a win. The 656-woman observational study had no placebo arm and the company's release did not mention the FDA black-box warning for liver injury.
Drugs & FDAA Fentanyl Vaccine for Mice. An Overdose Decline for Humans.
Scripps 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 & FDAA DoD-Funded Fentanyl Vaccine Is Headed to Phase 1. Antibodies Don't Stop a Supply Chain.
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 & FDAMedicare's Product-Hopping Loophole Is Back On The Chopping Block. The Bigger Pharma Giveaway Isn't.
The 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 & FDAEurope had this sunscreen in 1999. The FDA approved it Tuesday.
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 Macaques Get a Reprieve. Pharma Gets a Faster Pipeline.
The 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 Bet $2 Billion on AI-Designed RNAi. The Check It Actually Wrote Was $30 Million.
Alnylam 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 & FDAThe 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.
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.