fda
41 stories tagged "fda"
For Sixty Years the Screwworm Was Gone. It's Back in Texas, and the FDA Reached for Its COVID-Era Emergency Powers.
The flesh-eating fly the US wiped out in 1966 has crossed the southern border into Texas, and Washington's answer leans on the same emergency law it used for COVID drugs, this time to slap an emergency label on Zoetis's best-selling dog pill.
InvestigationsA Chinese Registry Marked the Trial 'Complete.' It Never Mentioned the Boy Who Died.
A boy died in a Chinese gene-therapy trial in August 2025. Months later the registry marked the study 'complete' and never mentioned him. He is one of three deaths now pulling Congress toward the trial data U.S. drugmakers ship home from China, while American inspectors almost never see the sites th
Drugs & FDAThe FDA Is Building an On-Ramp for Medical AI That Can Hallucinate
The FDA has cleared more than 1,000 AI medical devices and not one large language model. Its new discussion paper starts building the pathway for the ones that can make things up, with faster delivery to market named as an agency priority.
Drugs & FDAA $2.7 Million Gene Therapy, Approved Because Patients Needed Less Cornstarch
Ultragenyx's Genglycos won accelerated approval on a surrogate: a 31 percent cut in daily cornstarch. But the disease is low blood sugar, and by the company's own numbers the treated group spent slightly more time below 70 mg/dL, while liver enzymes spiked in 71 percent and every patient needed ster
Nutrition & FoodThousands of Genes, 20 Volunteers, No Control Group: The Viral Orange Juice Study
The juice came from a citrus-growers' group, the study had no comparison drink, and 'thousands of genes' rests on 20 people, arriving the same summer the FDA loosened what counts as orange juice.
Drugs & FDAThe Screwworm America Eradicated With Sterile Flies Is Back, and This Time Washington Also Reached for an Emergency-Authorized Chemical
Dicyclanil, an Australian sheep-blowfly chemical with mouse liver tumors in its toxicology file, is now cleared for cattle, swine, goats and wildlife under section 564, the same emergency-use power heavily used for pandemic countermeasures.
Drugs & FDAThe FDA's Reviewers Called This Melanoma Data 'Not Interpretable.' Nine Days Later, the Agency Approved the Drug.
Twice the FDA rejected Replimune's engineered-herpes melanoma therapy, its reviewers calling the single-arm trial not interpretable. The design never changed. A 10-3 advisory vote came anyway, and nine days after that memo, the accelerated approval.
Infectious DiseaseThe FDA Put an Emergency Label on a Zoetis Dog Pill for a Screwworm America Erased in 1966 Without a Single Drug
The sterile-fly barrier that kept the flesh-eating screwworm out of America for sixty years gave way, and Washington's answer has been a run of emergency drug authorizations, the newest for a Zoetis dog pill whose maker's own release cites no efficacy data against the parasite.
Metabolic & WeightThe Peptide Boom Hides One Divide: Human Trials on a Few, Rodent Data and Case Reports on the Rest
Semaglutide and tirzepatide erased up to 22 percent of body weight in trials with thousands of patients. The research-only peptides sold beside them, like BPC-157, have not completed a single published human efficacy trial. A popular 2026 guide lists them as equals.
InvestigationsOne Irish Plant Releases Both of Sanofi's Pompe Enzymes. In June, the FDA Called Its Drugs 'Adulterated.'
One Irish plant runs the final release for both of Sanofi's lifelong Pompe enzymes. It just failed an FDA inspection on that exact step, and now the company says the fix could take months while patients confirm their next shipments.
InvestigationsRFK Jr. Promised Radical Transparency. His HHS Gutted the Staff Who Release FDA Inspection Reports and CDC Outbreak Data.
The FDA, CDC, and NIH fielded more than 15,000 records requests in 2024. In April 2025 HHS fired the staff who answer them, rehired some FDA workers a month later under legal pressure, and by August 2026 the federal records backlog had only grown.
Drugs & FDAThe FDA Approved Moderna's mRNA Flu Shot for Seniors Without Proving It Works in Them
In February the FDA's own vaccine chief refused to even review it. One week later the agency reversed course, and the trial data never changed.
Autoimmune & InflammationThe Finest Immune Map of the Sarcoid Lung Explains Why Its Targeted Drugs Keep Failing
National Jewish Health charted more than 150,000 immune cells from sixteen sarcoidosis patients and found a disease with too many moving parts for any single drug to switch off. The targeted therapy that got furthest had already failed Phase 3 and erased 83 percent of its maker's value.
Drugs & FDAThe FDA Said No to Moderna's mRNA Flu Shot in February. By August, the Two Men Who Said No Were Gone.
The FDA refused to even review Moderna's mRNA flu shot in February because it was never tested against the enhanced vaccines seniors are steered toward. The two officials who objected are gone, and the agency approved it anyway, for the oldest patients, on a promise to prove it works later.
Infectious DiseaseMexican Jalapeños Sickened 1,400 Americans in 2008. Eighteen Years Later, a Different Farm and the Same Import Gap Did It Again.
Salmonella Javiana in jalapeños from Sinaloa has sickened 345 people across 27 states. It is the second time in eighteen years that imported Mexican peppers have done this, and the FDA still physically inspects only about 1 to 2 percent of the food crossing the border.
Drugs & FDAThe FDA Twice Called This Melanoma Trial Uninterpretable. Then It Approved the Drug, at $450,000 a Course.
Federal reviewers rejected Replimune's melanoma therapy twice, faulting a single-arm trial they called not adequate and well-controlled and its results uninterpretable. No new controlled data ever answered them. After a 10-3 advisory vote, the FDA approved it anyway, at $450,000 a course.
Drugs & FDAU.S. Special Operators Carried French Freeze-Dried Plasma for 15 Years Before the FDA Licensed an American One
Allied militaries and U.S. commandos have relied on freeze-dried plasma for years. Washington licensed its own version this week, decades after an American doctor first invented the powder.
Drugs & FDAThe FDA Cleared a CRISPR Cure for Two-Year-Olds Whose Own Trial Enrolled No One That Young
Casgevy's pediatric trials enrolled 11 children aged five and up, yet the FDA extended the $2.2 million therapy down to age two, where the conditioning chemo can permanently sterilize a child too young to bank eggs or sperm.
Nutrition & FoodThe FDA Revoked Two Petroleum Dyes That Industry Abandoned Before Most Americans Were Born
Orange B was last certified in 1978. Citrus Red No. 2 has painted Florida oranges since 1959. The six petroleum dyes actually in the food supply remain on a voluntary timeline no manufacturer has publicly signed.
InvestigationsA Pharma-Funded Nonprofit Is Lobbying the FDA to Kill Seven Peptides It Can't Sell You
The Partnership for Safe Medicines has deep ties to the drug lobby. Now it's urging the FDA to permanently block BPC-157, MOTS-c and five other off-patent peptides that compounding pharmacies sell cheap.
Drugs & FDAFor Years, a Foreign Factory Could Put the Active Ingredient in Your Medicine and Never Tell the FDA
The FDA led with a paperwork convenience for manufacturers. Buried underneath was the admission that it can't always trace where a drug's active ingredient was made, a blind spot Congress had to order it to close.
InvestigationsNEJM Retracted the Study That Approved Amgen's Vasculitis Drug. It Had Never Done That in 200 Years.
The FDA says the drug's superiority result came from re-scoring nine patients after the trial was unblinded. It is still on U.S. shelves while Amgen fights the withdrawal.
Drugs & FDAThe FDA Cleared a Sickle-Cell Cure for Two-Year-Olds in 53 Days. It Starts With Chemo That Can Sterilize Them.
Casgevy is a real advance against a brutal disease. It is also a $2.2 million therapy that requires sterilizing chemotherapy, saw a child die in trials, and reached toddlers on a 53-day review Makary's FDA hands out as a favor.
Drugs & FDAThe FDA Office That Vets Gene Therapy Has Run Through Its Entire Top Tier in a Year
The office that decides whether gene therapies reach patients has lost its director, her deputy, and the man brought in to replace them, all inside twelve months.
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.
InvestigationsHis Heart Was Pumping at 10 Percent. The Real Question Is Why It Took an Algorithm to Notice.
An AI tool flagged a 45-year-old's hidden heart failure and the story became 'AI beats your doctor.' The case actually documents a missed standard workup, and it dropped the same week as the FDA clearance.
InvestigationsThe AI Models Just Failed the Clinical Test We Use to Spot Executive Dysfunction
A new PNAS Nexus study put the same Stroop task neuropsychologists use to screen for executive dysfunction in front of GPT-5, Claude Opus, and Gemini. The accuracy collapse arrives months after the FDA quietly loosened oversight of AI clinical decision support.
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 & 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 & 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.
InvestigationsAaron Siri Wrote a Book Made of Court Filings
A new book by attorney Aaron Siri assembles a decade of FOIA wins, court filings, and depositions into one record of what the federal vaccine docket does and does not say.
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.
CancerPancreatic cancer's undruggable wall just cracked. The follow-up is 8.5 months and the money was already placed.
Revolution 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 & 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 & 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 & 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 & 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.
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 & 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.