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Summit'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.
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.
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.
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.
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.
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 & 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.