fda
81 stories tagged "fda"
Most of Finland's 'Low T' Men Reported Good Health 15 Years On, Even at Levels One Online Clinic Set Out to Treat
Finnish men in the bottom quarter for testosterone at 31 reported health and quality of life at 46 that didn't differ significantly from the top quarter, though their median level fell under the only treatment cutoff a 2022 secret-shopper study found among online platforms.
Drugs & FDAThe PTSD Magnet Therapy Touting 68 Percent Remission Hasn't Shown Its Placebo Arm
In Wave Neuroscience's earlier sham-controlled trial, veterans on a coil built to deliver no magnetic field improved about two-thirds as much as those on active stimulation. The sham results from the trial behind its FDA clearance still haven't been posted.
CancerCompass Plans to File a Biliary Cancer Drug Without the Survival Trial the FDA Asked For
Tovecimig plus chemotherapy shrank more biliary tract tumors than chemotherapy alone, but median survival was 8.9 months against 9.4, and 93.5 percent of the combination arm had grade 3 or worse adverse events. The FDA recommended a survival trial before filing. Compass plans to file anyway.
Drugs & FDASix Months Against Twelve: How Essilor's New Myopia Lens Got Called 'Twice as Fast'
Stellest 2.0's six-month numbers sat close to the original lens's one-year result from a separate trial, and a company symposium in London called that twice as fast. The children's lens is on sale abroad and has not been cleared by the FDA.
Drugs & FDAGSK's Hepatitis B Drug Got a Label That Reaches Patients It Functionally Cured About One Time in 14
Below 1,000 IU/mL of surface antigen, 26 percent of treated patients reached functional cure. Between 1,000 and 3,000, a range the FDA's label also covers, GSK's own counts work out to about 7 percent, for a weekly injection boxed for serious liver reactions and low platelets.
CancerThe Number Behind GSK's Rectal Cancer Approval Is 47 Percent, Not 76
Independent reviewers confirmed a year-long complete response in 54 of 116 AZUR-1 patients. GSK's release also carried an exploratory 76 percent. For a narrow slice of rectal cancer patients, the drug may still spare them radiation and surgery.
Drugs & FDAThe FDA Fast-Tracked GSK's Rectal Cancer Drug and Left the Trial's Own Scorecard Out of Its Announcement
Independent reviewers found 47 percent of evaluable AZUR-1 patients held a complete response for a year, the trial's registered endpoint. The FDA's announcement quoted friendlier measures instead.
Drugs & FDATwenty-Six Days After Altria Sued, the FDA Said It May Scrap Its Vape Rulebook
Out of 26.6 million nicotine-product applications since 2020, the FDA authorized 75. Now, with a tobacco giant's lawsuit named in its own notice, the agency says it may replace the whole framework.
Drugs & FDAAfter 56 Years of 'No Accepted Medical Use,' the FDA Wants Help Testing Ibogaine
Howard Lotsof said one dose ended his heroin withdrawal in 1962. The same alkaloid can stop a heart. The FDA has opened 45 days of comment on how to test it without killing anyone.
Drugs & FDAKennedy's Peptide Plan Reaches the White House, and Wall Street Is Already Counting the Money
Peptides already sell on a Queens bodega shelf, so moving them into licensed pharmacies is progress. Whether it protects anyone depends on one missing rule: test each lot and report every injury.
Drugs & FDAFDA's Anktiva Approval for Papillary-Only Bladder Cancer Cites No Papillary-Only Patients
Seventeen months after refusing even to review ImmunityBio's application, the FDA expanded Anktiva's label by extrapolating from carcinoma in situ, and its announcement never mentioned the 80 papillary-only patients the company had actually studied.
Drugs & FDATerence Tao Fears a Cancer Cure Nobody Can Explain. The FDA Clears Cancer Drugs That Never Proved They Extend Life.
Terence Tao says he would want a human expert to understand an AI cancer cure before taking it. The oncologist Vinay Prasad says that misses how medicine already works, and the receipts show the cancer drugs worth fearing are the legible ones approved on a shrinking tumor that never proved they help
Drugs & FDAGaming a Cancer Trial Is 'Cheap and Easy,' Says a Former Top FDA Official
Vinay Prasad says nobody needs AI to fake a phase 3 cancer win, and a Mayo Clinic audit found 16 of 96 FDA cancer approvals rested on control arms its authors judged suboptimal.
Infectious DiseaseForty-Five Years After Acyclovir, the FDA's Herpes Headline Is a Warning Letter to Amazon
Some 520 million people carry the virus behind most genital herpes, and no drug clears it. The FDA's October move was a warning letter over herpes ointments and washes sold on Amazon.
Drugs & FDAThe FDA's Former Biologics Chief Says Public Health Can't See the Next Disaster Coming
Vinay Prasad ran the FDA's biologics center until this spring. His warning: the apparatus chases lettuce recalls and measles while a blood test for dozens of cancers heads toward Medicare with its central question unanswered.
InvestigationsThe FDA Is Recruiting New Advisers Without Publishing the Rule for Who's Too Conflicted to Sit
Acting commissioner Kyle Diamantas is inviting scientists and 'consumer voices' onto the FDA's advisory panels. The agency has never published how it decides which of them carries a disqualifying conflict, thirteen years after Congress ordered it to.
Drugs & FDAFederal Agents Seized Counterfeit Ozempic and Warned the Public. Prosecutors Say the Smuggling Kept Going for Months.
The counterfeits came from China with fake needles and packaging and sold to distributors at a discount. The indictment says the alleged scheme kept running for months after the FDA had already seized counterfeit Ozempic and warned the country.
InvestigationsThe FDA Will Now Accept Real-World Evidence for Devices Without the Patient Records Behind It
The curation that turns raw medical charts into "regulatory-grade" evidence happens inside private vendors like Roche-owned Flatiron Health. The public record does not show who, if anyone, independently audits it.
InvestigationsKennedy's Ultra-Processed Food Rule Leaves Open the Loophole He Promised to Close
In February he vowed to act on the petition that demanded real safety review of food additives. In August his FDA proposed a rule that still lets companies certify their own chemicals as safe, and sell them before anyone at the agency looks.
InvestigationsA Warehouse Stored Infant Formula Among 26 Rodents. After 32 Inspections, No One Was Charged.
The FDA found infant formula stored among 26 rodents at a Minneapolis warehouse the state had inspected 26 times since 2013. The remedy was a cleanup order and no charges, the same month the Justice Department let Abbott pay nearly $385 million and close its own formula criminal case with no one cha
Drugs & FDATrump's FDA Nominee Backed Cutting the Vaccine Schedule, Then Hid Behind 'Safe and Effective' Under Oath
Heidi Overton stood beside Trump as he cut the childhood vaccine schedule from 18 diseases to 11. At her confirmation hearing she spent two hours calling every FDA-approved vaccine 'safe and effective' and refused to defend the reform she coordinated.
Drugs & FDAThe FDA's New Fast Lane for Experimental Drugs Is Run by a Lawyer Who Defended the Food and Tobacco Industries
Operation TrialBlazer lets drug sponsors feed their first-in-human safety data to the FDA in pieces, on a rolling clock, to shave months off the wait. The review it speeds is the one that decides whether an untested drug can go into a person at all.
Drugs & FDAThe FDA Warned a Generation Off Hormones. A Danish Registry Puts the Clot Risk in the Pill, Not the Patch.
Oral hormone therapy was tied to more clots, and to strokes and heart attacks at higher doses taken longer. The patches and gels carried no general increase. The warning that scared a generation of women off never drew the line.
Drugs & FDANo FDA-Approved Drug Stops Preterm Labor: a Vanderbilt Screen of All 1,191 Approved Drugs Landed on an Asthma Steroid
Every drug used to halt preterm contractions is borrowed off-label; the FDA has never approved one for the job. A Vanderbilt team screened all 1,191 approved drugs and landed on an asthma steroid.