Drugs & FDA
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Mice Trained to Spot THC Gave the THC Answer for CBN, the Sleep-Gummy Cannabinoid
Mice given CBN twice daily for five days grew tolerant and twitched once a receptor blocker cut it off. A Canopy Growth sleep trial of CBN found about 0.5 fewer awakenings a night and missed its main measure.
Drugs & FDAHeart Failure Admissions Ran 3.7 Percent Higher for Every Year the West Sold Legal Pot
Fifty million discharge records tie each year of Western dispensary sales to higher heart failure, heart attack and atrial fibrillation admission rates, while the federal rescheduling fight sits frozen before a DEA judge.
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.
Drugs & FDABlood Pressure Fell Further on the Switched-Off Ear Clip Than on the Real Device
Daytime systolic pressure fell 5.50 points on a zero-current fake ear clip and 3.15 on the active device. Queen Mary's headline said the stimulation "shows potential."
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.
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 & FDAVaping Beat the Patch in the Strongest Evidence Yet. The WHO Told Governments Not to Allow It.
Eighty randomized trials and nearly 30,000 people put nicotine vapes ahead of patches and gum, with high-certainty evidence. More than half of adults believe vaping is as dangerous as smoking. The agencies that warned them never had the trial data on their side.
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 & FDAThe First-Line Glaucoma Drop That Flatters Its Own Pressure Reading
Across 128 eyes followed at one VA clinic, the corneas that thinned most on prostaglandin drops made the pressure gauge read 3.3 mm Hg low, and those eyes lost visual field nearly twice as fast.
Drugs & FDAThe FDA's 'Historic' Growing Heart Valve Has Been Stretched in Two Children
Children who get a new heart valve before age 2 can face up to five open-heart surgeries. Edwards' polymer valve is built to end that, and the trial behind its approval widened it in two of 62 kids.
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 & FDAA Hundred Thousand Dollars, Two Inches, and a New Calculator for Sorting Short Children
About $100,000 buys a healthy short child two inches of height. A new calculator predicts who responds best, and it joins a field where some of the biggest datasets belong to the companies selling the hormone.
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 & FDAGenSight's Blindness Gene Therapy Reached the NEJM on the Same Day It Reported €0.7 Million in Cash
Seven of ten patients blinded by retinitis pigmentosa sensed more light through special goggles after one gene injection, in an uncontrolled trial whose sponsor held €0.7 million on September 30 and warned it may not survive the year.
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 & FDAA Heart-Failure Implant Won by 40 Points on a Questionnaire Filled Out by Patients Who Knew Which Arm They Were In
Patients given Berlin Heals' microcurrent implant reported quality-of-life gains eight times the control arm's in an open-label trial. The blood marker and exercise test that could have backed them up showed no significant difference, and the company paid for the study.
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.
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.
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.
Drugs & FDAOne Hormone Starves the Brain and Floods the Heart: The FDA's First MCT8 Drug Treats Only the Flood
Emcitate is being called the first treatment for MCT8 deficiency, but its FDA label covers the racing heart and the wasting body, not the brain disability that defines the disease.
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.