For how we live.
A section 564 declaration, prompted by a July determination from the Secretary of War, opens the door to authorising unapproved drugs for acute pain in combat and CBRN casualties.
A draft replacing a 2003 document would extend hepatic-impairment dosing studies to biologic drugs and to drug effects, not just blood levels. It is open for comment before the agency finalises it.
Cochrane found composite resin restorations had almost double the failure rate in children's permanent teeth. The FDA does not recommend removing intact amalgam fillings from anyone.
A supplement approved on 26 August adds SURPASS-CVOT to the prescribing information and rewrites the eye warning so it is addressed to patients with a history of retinopathy rather than to patients with diabetes.
A researcher who expected the evidence base to be thin says even she was surprised by how thin. Most cleared devices never appear in a registered clinical trial at all.
Post-bariatric hypoglycemia hits roughly 1 in 12 gastric bypass patients with sudden blood sugar crashes. Avexitide cut severe events by 55% against placebo.
Six products got revised labels in February 2026, removing cardiovascular, breast cancer, and dementia language. The scientific societies that welcomed the change also listed the distinctions the new label does not make.
A new discussion paper proposes a two-axis risk framework and a physician-training analogy for evaluating generative AI devices. It is not a rule, and the agency is asking what one should look like.
Tirzepatide has been approved for obstructive sleep apnea since December 2024. A January 2026 reanalysis of the trial behind that approval separates what weight loss fixed from what treating the breathing fixed.
Zenbexus didn't have to outlive patients in a control arm to win approval — it had to clear their bone marrow of detectable disease faster. That shortcut is becoming the norm, not the exception.
Orzeyful replaces signaling from the brain chemical narcolepsy patients lack, rather than stimulating wakefulness around the gap. Two-thirds of patients on the higher dose had trouble sleeping.
For decades a manufacturer could add a new ingredient and privately decide it was generally recognized as safe without telling the FDA. A proposed rule would end that loophole.
GENGLYCOS treats the cause of glycogen storage disease type Ia, not just the symptoms cornstarch regimens manage — but it carries a long list of serious risks and an accelerated-approval asterisk.
The Aletta still needs a trained supervisor in the room, but it locates the vein, inserts the needle and fills the tubes on its own — and one person can now watch three of them at once.
Orforglipron removes the injection from weight-loss medicine — a real change for people who refused one. Supply, cost, and coverage are the harder problems it does not solve.
The agency compressed review of three psychedelic therapies from a year to weeks. A first approval decision is plausible by early 2027.
It found no meaningful difference at six weeks. It enrolled 64 people, tested one device, and ran for six weeks. That is the entire head-to-head evidence base three years after the category opened.
A generic must prove its absorption matches the brand within a defined statistical window. Across 2,070 FDA studies the average gap was under 5%. Generics are 90% of prescriptions and a fraction of the cost.
The FDA's approval bar requires no clinically meaningful difference from the original, and a large switching trial found no loss of control. The savings gap is a market problem, not a safety one.
The FDA's own trials found every chemical filter tested crossing a regulatory threshold after a single application. That threshold triggers safety studies; it is not a finding of toxicity.
In February, FDA said it intended to act against compounded GLP-1 supply without saying how. The answer arrived in May: exclude semaglutide, tirzepatide and liraglutide from the list.
A comparison of 2020–2025 approvals finds 94 novel oncology drugs from the NMPA against 87 from the FDA, with China's volume overtaking from 2023. The speed and first-in-class figures run the other way.
Simtriyo works on a different neurotransmitter pathway than existing stimulants. But its own manufacturer classifies it as a CNS stimulant, so a scheduling review stands before pharmacy shelves.
Lipfendra cut LDL cholesterol by more than half in two trials. Its significance is less the number than the format: a once-daily tablet where every prior PCSK9 inhibitor required a needle.
An analysis of the FDA's voluntary reporting database finds herbal and weight-loss products carry the highest serious-outcome rate. The author is explicit that these are flags for investigation, not proven risks.
In a 187-patient trial, chronic graft-versus-host-disease-free survival at one year was 78% with the new therapy versus 38% with conventional transplant. The FDA approved it 30 June.
Bemotrizinol, a UV filter available in Europe and elsewhere since the early 2000s, cleared US regulatory review this month — more than a decade after a manufacturer first flagged it to the FDA.
Xocova is taken after a known exposure, not after symptoms appear. In a 2,041-person trial it cut symptomatic infection by 67% through day 10.
Hepcludex clears a bar most rare-disease drugs never reach: full U.S. approval. But FDA granted it on a surrogate marker, denied a bonus review voucher, and wants outcomes data that won't arrive until 2034.
The agency granted its first authorization for a software-aided adjunctive diagnostic device in wound assessment, a category built for tools that analyze a wound optically.
Baxdrostat blocks the enzyme that makes aldosterone, rather than blocking aldosterone's receptor. In a 794-patient trial it lowered systolic pressure another 10 points in people already on multiple drugs.
About one in five adults with generalized myasthenia gravis test negative for the antibody Vyvgart was built around. A new trial, and a new approval, brings them into its label.
GE's Critical Care Suite gains an algorithm that flags misplaced enteric tubes on a chest X-ray — a complication that reviews of the practice have linked to respiratory harm and, in some cases, death.
Sparsentan cut proteinuria nearly in half in the DUPLEX trial's FSGS patients. Its effect on the eGFR measure that tracks actual kidney function decline was smaller, and comes with a liver-monitoring requirement.
Louisiana wanted mail and telehealth access to the drug shut down immediately. The judge denied that request but didn't dismiss the case either — he gave the FDA until October to finish its own review.
A content analysis of every FDA cybersecurity safety communication from 2013 to 2025 finds a small corpus, rising over time, and 94% of the flagged vulnerabilities rated severe.
The clearance is the third in a growing family of machine-learning notification algorithms built to spot serious cardiac conditions from a routine 12-lead ECG, a test most patients already get.
Awiqli's approval for adults with type 2 diabetes rests on four trials comparing it with daily basal insulin. A pediatric dosing study is still due by June.
The draft Plausible Mechanism Framework would let a well-supported mechanism of action carry weight where patient populations are too small for randomisation. It is open for comment for 60 days.
The agency announced an intent to restrict GLP-1 active ingredients destined for non-approved compounded drugs, and warned that seizure and injunction are on the table without further notice.
FDA approved copper histidinate on the strength of two single-arm trials compared with an external control group. Children treated within four weeks of birth had a 78 percent lower risk of death.
Revised guidance reverses the 2022 position that a single recommendation made software a device. The agency's own criterion — that a clinician can independently review the basis — now carries the weight.
The agency says it has been relaxing chemistry and manufacturing expectations for cell and gene therapies case by case. The change is that every sponsor now knows it.
The FDA's revised general wellness policy lets non-invasive devices infer blood pressure, glucose and other physiologic parameters. The regulated line is no longer the measurement — it is the sentence next to it.
The NEJM paper reports 47 children in an open-label trial with no randomised control. The biomarker effect is large; the clinical claim rests on softer ground.
One agency asked how to measure AI devices after they are deployed. Another asked how to speed adoption up. The offices that would answer the first question are losing staff.
FDA cleared oral semaglutide 25 mg on 22 December for chronic weight management and cardiovascular risk reduction. Its self-pay price, not its efficacy, is what may distinguish it.
The line saying a product is not intended to diagnose, treat, cure or prevent disease must sit beside each health claim. Industry asked for that to change; the FDA says it may propose a rule.
Zoliflodacin is the first antibiotic developed solely for gonorrhoea in decades, and a non-profit holds the rights to register it across most of the world.
At a Mayo Clinic cohort of 252 patients, 40% of amyloid-negative people tested positive. The manufacturer says it has found a manufacturing problem and put the product on hold.
Bristol Myers Squibb found 'irregularities' in how a small number of ADEPT-2 sites executed the study, excluded their patients, and is enrolling more. Alzheimer's-related psychosis still has no approved treatment.
Voyxact cut urinary protein by about half at nine months in the VISIONARY trial. Whether that slows kidney decline is the question the accelerated approval leaves open until 2027.
A systematic review of every AI device authorised from 1995 to June 2024 found 97% cleared through the 510(k) pathway, which does not require independent clinical data on performance or safety.
Hyrnuo (sevabertinib) is cleared for previously treated HER2-mutant NSCLC on response rate alone. The confirmatory trial that must justify it does not report until 2029.
Redemplo (plozasiran) is dosed once every three months. The approval carries required studies on liver injury, dysglycaemia and carcinogenicity, and skipped an advisory committee.
Kygevvi is a pair of oral nucleosides for an ultra-rare mitochondrial myopathy. There was no randomised trial — survival in treated patients was compared with untreated patients drawn from the literature.
Lynkuet is the second neurokinin-targeted drug cleared in the US for vasomotor symptoms. The trials found no hepatotoxic effects; FDA still asked for three years of enhanced liver-injury reporting.
Jascayd cleared on 7 October under priority review with orphan designation. The phase 3 trial it rests on measured lung function decline, not survival, and most patients were already on an antifibrotic.
A census of 691 AI-enabled devices cleared through 2023 found demographic data missing almost everywhere, three summaries reporting patient outcomes, and 113 recalls driven mostly by software.
Palsonify is cleared for adults whose acromegaly did not respond adequately to surgery. In the phase 3 switching trial, 83.3% on the pill kept biochemical control versus 3.6% on placebo.
Forzinity was approved under accelerated approval to improve muscle strength in patients weighing at least 30 kg. The confirmatory trial is not due to report until 2030.
Brensocatib blocks an enzyme that arms neutrophils rather than killing bacteria. In a 1,721-patient trial it cut yearly flare-ups by about a fifth — a modest effect in a disease with nothing else approved.
Sebetralstat was approved on 3 July for patients aged 12 and older. In its pivotal crossover trial, 76% of attacks treated with the 600 mg dose began to ease within 12 hours, against 49% on placebo.
Lenacapavir is the first HIV pre-exposure prophylaxis given every six months. Two phase 3 trials found zero and two infections in the lenacapavir groups against background rates above 2 per 100 person-years.