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The FDA's New Pilot Lets a Drug Sponsor Choose the Institution Helping Build Its First-in-Human Application, and Reviews the Pieces as They Arrive
The agency will select 8 to 10 sponsor-QRI pairs to co-develop first-in-human trial applications it reviews on a rolling basis, and its stated reason is that China and Australia get there faster.
InvestigationsThe Government Is Keeping Almost All of Abbott's $385 Million Formula Settlement. The Families of the Dead Infants Get Nothing.
Abbott will pay $385 million over the plant tied to two infant deaths. Almost every dollar reimburses Washington's own nutrition programs, three whistleblowers split $69 million, and the families get nothing. The DOJ dropped the criminal case after Abbott gave $500,000 to the president's inaugural f
Drugs & FDAA Fatal Brain Disease in Children Finally Has a Drug, and It Lists at $1.14 Million a Year
Ionis's zilganersen is the first therapy ever approved for Alexander disease, and it lists near $1.14 million a year. The same FDA approval handed Ionis a rare pediatric disease voucher, the transferable coupon that has resold for as much as $350 million.
Drugs & FDAThe FDA Approved a Breast Cancer Drug Its Own Advisers Had Just Rejected, 6 to 3
An FDA advisory panel voted 6 to 3 that AstraZeneca had not shown its breast cancer drug delivered a meaningful benefit. The agency approved it four months later anyway.
Drugs & FDASickle Cell Finally Has a Cure. It Costs $2.2 Million and Has Reached 64 People.
Casgevy has kept Victoria Gray crisis-free for seven years. Getting it still means wiping out a patient's bone marrow with a chemo tied to infertility and malignancy warnings and paying about $3 million all in, and two years after approval only 64 people have been infused.
Infectious DiseaseThe FDA Is Fighting a Flesh-Eating Parasite We Eradicated in 1966 With a Flea Pill From 2000
Nitenpyram was approved in 2000 to kill fleas. It is now the emergency tool against a parasite the United States wiped out in 1966, after the sterile-fly barrier that kept the screwworm out was breached in 2023.
Drugs & FDATwo Factories Make the Starter IV Nutrition America's Preemies Live On. Both Are Closing, and the Backup Plan Has Killed Babies Before.
The predominant source of starter IV nutrition for premature newborns is two outsourcing facilities, and both are permanently closing. The FDA's fix: let hospital pharmacies mix it themselves for 180 days, sending the most unforgiving product in medicine back into the loosely regulated compounding t
Drugs & FDAThe FDA Has Approved 4 Plant Drugs Since 2004. Now It's Asking the Public Why So Few Made It.
A request for public input is not reform. After two decades of a pathway that produced four approvals, the question is whether the agency wants plant medicine or just wants to talk about it.
CancerSummit's $500 Million Lung Drug Split the Curve Patients Can't Feel
Ivonescimab delayed tumor progression by 2.4 months in EGFR-mutated lung cancer, but its overall-survival curve never cleared statistical significance and serious treatment-related adverse events nearly doubled.
Drugs & FDAIonis Priced the First Alexander Disease Drug at $1.14 Million a Year, and Got a Federal Voucher It Can Resell for More Than $100 Million
Zilganersen is the first drug for Alexander disease, an antisense therapy designed to lower the toxic protein that drives a fatal brain disease. It also carries a $1.14 million annual price and a pediatric voucher Ionis can resell for more than $100 million.
Drugs & FDAThe FDA Approved a Breast Cancer Drug Four Months After Its Advisers Voted No
On April 30 the FDA's oncology advisers voted 6 to 3 that AstraZeneca's camizestrant hadn't shown a clinically meaningful benefit. On September 4 the agency approved it anyway, conceding in its own approval that the benefit is "not yet confirmed."
Drugs & FDAChina Runs More Drug Trials Than America. The FDA Says It Can No Longer Trust Data From Sites It Can't Inspect.
China went from under 8 percent of the world's drug trials in 2010 to passing the United States by 2020. After three deaths in Chinese studies surfaced late, the FDA says it has sometimes been denied access to the very sites whose data underpins American approvals.
Drugs & FDAThe Pancreatic-Cancer Pill That Doubles Survival: $39,800 a Month, and a Fast Lane Congress Never Approved
Rasonque roughly doubles median survival in metastatic pancreatic cancer. Revolution Medicines priced it at $477,600 a year, more than double Keytruda, and the FDA cleared it early through a voucher program lawmakers say Congress never authorized.
Infectious DiseaseFor 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.
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.
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.
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 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.