For how we live.
A final FDA guidance treats the on-screen output of software sent with a prescription drug as a type of drug labelling, and says how the prescribing information should describe it and when sponsors submit it for review.
GSK's PD-1 blocker won accelerated US approval on 19 October for previously untreated stage II/III dMMR rectal cancer. In the single-arm AZUR-1 trial, most patients avoided surgery, radiation and chemotherapy.
A final FDA guidance sets out the safety information companies should provide when notifying the agency of a new dietary ingredient, replacing the old 'comprehensive safety profile' with a single 'safety narrative.'
The FDA approved Tecentriq on 8 October, with chemotherapy, for Stage III mismatch repair deficient colon cancer after resection. In ATOMIC, adding it cut disease-free survival events, hazard ratio 0.50.
The agency authorised emergency use of four veterinary products to prevent or treat New World screwworm infestations, acting on a 2025 declaration that the parasite poses a potential public-health emergency.
The Fit-for-Purpose Rare Disease Framework Initiative launches with a 28 October public meeting and a request for comments. The FDA wants to tailor its review to very small patient populations.
On 13 October the FDA extended Velphoro (sucroferric oxyhydroxide) to children aged 6 to 9 on dialysis and added a 250 mg chewable tablet, widening an iron-based binder previously limited to patients 9 and older.
A 9 October labelling supplement folds results from two post-marketing rheumatoid-arthritis safety studies into the JAK inhibitor baricitinib's boxed warning, and revises its infection and cardiovascular sections.
Hovilpri (pritelivir), a helicase-primase inhibitor, was approved on 9 October for immunocompromised adults whose herpes lesions resist aciclovir. In its trial, 63% healed by day 28 against 34% on comparator therapy.
On 14 October the FDA extended nogapendekin alfa inbakicept-pmln, with BCG, to BCG-unresponsive papillary-only disease - a first for that group - without a new trial, by extrapolating from its carcinoma-in-situ data.
A final rule amends 80 FDA standards of identity so makers can replace some or all added salt with substitutes, part of a push to cut sodium tied to high blood pressure. It takes effect 14 December 2026.
A final question-and-answer guidance tells biosimilar makers what data to file when they change how an approved product is made, fulfilling a 2022 user-fee commitment. It was issued on 13 October 2026.
Teva's subcutaneous depot is built to avoid the post-injection sedation that hobbled the first olanzapine shot. It cleared the FDA on 8 October; in the phase 3 SOLARIS trial it beat placebo on symptoms at eight weeks.
The pill joins trastuzumab and pertuzumab as maintenance after induction. In the 654-patient HER2CLIMB-05 trial it stretched median progression-free survival to 24.9 months from 16.3, a hazard ratio of 0.64.
Rhapsido becomes the first drug labelled for the itchy welts raised by scratching or pressure. In the RemIND trial, 29.3% on the pill cleared the provocation test at week 12 versus 14.0% on placebo.
The FDA logged the recall of the RED 62 reperfusion catheter, part of the Penumbra System used to pull clots from the brain, on 7 October. Manufacturing problems mean the device may fracture; 43 units are affected.
A final order published 9 October classifies the over-the-counter infant pulse rate and oxygen saturation monitor as class II, with special controls built around the risk that it fails to detect a pulse.
A final order published 9 October classifies systems that let people collect their own specimens for non-viral STI testing as class II, moving them out of the automatic class III that demands premarket approval.
A draft guidance published 9 October would spare mid-sized retail food establishments and restaurants from all Food Traceability Rule requirements. Comments close 23 November; a public meeting follows on 6 November.
A final order codifies Class II status for high-throughput DNA sequencing systems that detect germline mutations in cancer genes, built on Invitae's panel. It becomes a predicate other makers can clear against.
The agency issued the tradable voucher to Ultragenyx for FAYUVI, an AAV gene therapy for the neurologic features of MPS IIIA that it approved on 17 September 2026. Such vouchers can be redeemed or sold.
The agency is describing the trial design it is weighing for ibogaine, a psychedelic with serious cardiac risks, as HHS funds the first federal studies in opioid use disorder and PTSD. Comments close 20 November.
A final order codifies a new Class II category for systems that destroy soft tissue with sound rather than heat, built on HistoSonics Edison System. It becomes a predicate other makers can clear against.
A hybrid public meeting on 26 October will discuss proposed BsUFA IV recommendations. The fees that fund FDA review of biosimilar applications expire in September 2027 and need new legislation to continue.
An FDA advisory committee will meet on 30 October to review Sydnexis's atropine sulfate 0.01% eye drops, proposed to slow myopia progression in children aged 3 and older. The public docket closes 29 October.
AbbVie's once-daily pill cleared the FDA on 25 September as a new molecular entity. Across three phase 3 TEMPO trials it beat placebo in early Parkinson's and as an add-on to levodopa.
An order effective 25 September lets manufacturers use inactive baker's yeast to add vitamin D2 to cereals, grain products, milk and milk products, at the same limits already set for vitamin D2 mushroom powder.
A final order published 17 September denies a petition that sought to exempt four classes of computer-aided detection, diagnosis and triage devices from 510(k) clearance. Makers must keep filing before they market.
Merck's sotatercept gained an FDA efficacy supplement on 21 September. In the phase 3 ZENITH trial, a composite of death, transplant or hospitalisation hit 17.4% on the drug versus 54.7% on placebo.
The FDA approved PTC Therapeutics' sepiapterin in July 2025. In the phase 3 APHENITY trial, responders saw a 63% fall in blood phenylalanine over six weeks against roughly no change on placebo.
The FDA logged the recall of 8,939 StatStrip Glucose and B-Ketone meters on 23 September, after a software flaw let a scanned barcode linger and file a reading to the wrong patient. It is the agency's most serious tier.
The FDA logged the recall of 2,718 Medline convenience kits on 23 September: sterile applicators in some lots could grow the mould Aspergillus penicillioides, and contaminated skin-prep risks infection or sepsis.
Eli Lilly's oral Inluriyo gained an FDA efficacy supplement on 18 September. In the phase 3 EMBER-3 trial, adding abemaciclib lifted median progression-free survival to 9.4 months from 5.5.
The oral histone deacetylase inhibitor cleared the FDA in March 2024. In the phase 3 EPIDYS trial, boys on givinostat still lost function over 72 weeks — just less of it than those on placebo.
Emcitate cleared the FDA on 28 September as a new molecular entity. In an open-label trial of 45 patients, the drug lowered the high serum T3 that drives MCT8 deficiency by about two-thirds.
Bristol Myers Squibb's mavacamten gained an FDA efficacy supplement on 30 September. In the pivotal EXPLORER-HCM trial, 37% on the drug met the primary endpoint versus 17% on placebo.
The FDA logged the recall of 1,640 AVID single-shot epidural trays on 23 September, because they hold sodium-chloride ampules caught in a separate Class I sterility recall that warns of possible infection.
The FDA logged the recall of 5,232 Automated Impella Controllers on 23 September, citing a possible purge-pressure sensor failure that can leave the console unable to recognise the pump's purge cassette.
One lot of Vitruvias's 1/2-grain Thyroid Tablets — 1,955 bottles sold nationwide — was pulled after testing showed the tablets carry more hormone than the label states. The FDA calls it its most serious recall class.
Rezzayo's once-weekly echinocandin can now be used in adolescents with candidaemia who have few other options. The expansion rests on adult data and modelling, not on studies in children.
Two 2026 Class I recalls cover Omnipod 5 insulin pods whose soft cannula can be damaged in manufacturing, letting insulin leak instead of reaching the user. The FDA ties under-delivery to a risk of DKA.
A final order classifies the flushing and storage solution for vascular autografts as Class II with special controls, codifying a 2023 De Novo decision on Marizyme's DuraGraft and setting the bar for future copies.
BeiGene's PD-1 antibody, added to the HER2 drug zanidatamab and chemotherapy, lifted median overall survival to 26.4 months from 19.2 in the HERIZON-GEA-01 trial. The gain concentrated in the strongest HER2-expressers.
Cleared on 10 July under NDA 218579, the Provepharm agent fluoresces in near-infrared light to map vessels, perfusion and lymph nodes during surgery. Efficacy rests on studies of an earlier formulation.
The FDA logged a Class I recall of 35,883 boxes of the simethicone antigas product on 17 June, after softgels were contaminated with a propylene glycol-based coolant that leaked from packaging machinery.
Approved on 24 June under NDA 220436, the Avyxa Holdings product is a ready-to-infuse form of the NK-1 blocker fosaprepitant, cleared on studies of an earlier intravenous version of the drug.
The FDA logged the recall of 145,464 bags of 0.9% sodium chloride in 500 mL Viaflex containers on 9 September, after fiberglass particulate matter was found. It is the agency's most serious recall tier.
The Class I recall covers 625,500 prefilled syringes. Cartons labelled morphine sulfate 2 mg/mL hold a Dilaudid (hydromorphone) syringe of 0.5 mg/0.5 mL instead — the wrong opioid at the wrong dose.
Regeneron's activin A antibody, brand name Pasatru, cleared the FDA on 19 August. In the pivotal 63-patient trial, new abnormal-bone lesions fell by 90% or more against placebo over 56 weeks.
The FDA classified the nationwide recall Class I, its most serious tier. About 31,935 multi-dose vials are affected, with particulate identified as nylon, glass and other materials, plus broken and leaking units.
The Scholar Rock antibody cleared the FDA on 11 September. In the phase 3 SAPPHIRE trial, apitegromab plus standard therapy beat placebo by 1.8 points on a motor-function scale at 12 months.
A new draft guidance sets out the agency's current thinking on the non-clinical and clinical data it expects in premarket submissions for robotically-assisted surgical devices. Comments are due 24 November.
Rejoyn, the first prescription digital therapeutic cleared for major depression, beat a sham app on a backup analysis. Its pre-specified primary endpoint fell just short of significance.
A January 2025 draft guidance lays out the documentation the agency expects across an AI device's whole life, including bias checks across demographic groups and postmarket monitoring. It is not yet binding.
US regulators class MSG as generally recognised as safe, and when the symptoms are tested under blinded conditions they largely disappear. The clearest signal is a nocebo effect, not the additive.
A direct final rule swaps 'animal' for 'nonclinical' across five parts of FDA's drug regulations. It adds no requirements, but signals a shift the agency began with monoclonal antibodies.
Since 2024 the FDA has cleared over-the-counter CGMs for people who don't use insulin. The first independent accuracy check in adults without diabetes finds the sensors track the trend but miss the exact number.
EndeavorRx is a prescription game the FDA cleared in 2020 for children with ADHD. Its pivotal trial moved a computer attention score, but the FDA says it may not help the behaviour parents notice.
RelieVRx is an authorised virtual-reality therapeutic for chronic low back pain. Its trials show real improvement — but in a 1,067-person study the edge over a placebo headset was 0.4 points on a 10-point scale.
Abilify MyCite embeds a sensor in an antipsychotic tablet to log each dose to an app. Nearly a decade on, its own FDA label still says it has not been shown to improve whether patients take their medicine.
Rings and watches sold online promise needle-free glucose readings. The FDA says do not use any of them, and even research-grade non-invasive sensors miss the mark by about a fifth.
LITESPARK-022 cut the risk of recurrence by 28% when belzutifan was added to pembrolizumab after surgery. Survival was no different, and severe side effects nearly doubled.
Two trials found low-dose colchicine cut cardiovascular events, and the FDA approved it for heart risk in 2023. Then the largest trial found nothing, leaving the question genuinely unsettled.
A final order files AI tools that flag possible cardiovascular disease as class II with special controls, letting similar triage software clear via 510(k). The controls require real-world, subgroup-tested validation.
Cobenfy, approved in the US in September 2024, cut symptom scores more than placebo in two five-week trials — without the weight gain and movement effects of older drugs, but with cholinergic side effects.
The oral decongestant in most cold and sinus tablets — phenylephrine — works no better than placebo, US regulators now say. Saline and short-term sprays do more.
In a 258-patient phase 3 trial, the oral drug reduced transfusion needs in about 30% of adults with transfusion-dependent thalassaemia, versus 13% on placebo.
A predetermined change control plan is the FDA's answer to a model that keeps learning: pre-approve a bounded set of future changes, and the manufacturer can ship them without returning for a fresh review.
23andMe's cleared BRCA report reads 3 of more than 1,000 mutations, so a negative result is not the all-clear it looks like — and the firm's bankruptcy has put customers' genetic data in play.
The agency revoked Orange B and proposed dropping Citrus Red No. 2 because neither has been used in decades. It said the safety of synthetic colours is outside the scope of these orders.
New at-home molecular tests catch most established colorectal cancers, but find only 13–43% of the advanced precancerous polyps a colonoscopy is meant to remove before they become cancer.
In the SKYLARK trial, a 14-day course improved depression scores faster than placebo. The effect was real but modest, and the label carries a driving-impairment warning.
In LIBERTY 1 and 2, more than 70% of women with fibroid-related heavy bleeding responded to the once-daily pill, versus under 20% on placebo. The label caps use at 24 months over bone loss.
AD109 cut the apnoea-hypopnoea index by four events an hour more than placebo over 26 weeks. It did not improve fatigue, and one in five participants stopped because of side effects.
SERENA-6 changed therapy the moment a resistance mutation appeared in the blood, not when tumours grew. It nearly doubled time to progression — and won camizestrant FDA approval in 2026.
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.
In a 92-patient Greek cohort, the long-acting PTH replacement normalised calcium and phosphate and freed 58% of patients from calcium and vitamin D pills — echoing the trials, over a short follow-up.
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.
In HERIZON-GEA-01, zanidatamab plus chemotherapy raised median progression-free survival to 12.4 months from 8.1 with trastuzumab. A clear survival gain came only when tislelizumab was added.
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 dye is being pulled under a 1958 law that bans any additive found to cause cancer in animals, at any dose. FDA's own review calls the rat finding of limited relevance to people.
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.
Beqalzi (sonrotoclax) is approved for relapsed mantle-cell lymphoma after a BTK inhibitor. Just over half of 103 patients responded in a single-arm trial with no survival data.
In the FDA study, self-fitted AirPods matched a professional fitting for perceived benefit. Independent testing finds the hearing test accurate to about 10 dB — and the amplification short of a fitted aid.
In VERITAC-2 the oral degrader more than doubled progression-free survival over fulvestrant in patients with an ESR1 mutation — 5.0 months versus 2.1 — but not in the trial as a whole.
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.
Bizengri now covers NRG1-fusion cholangiocarcinoma, a mutation found in a fraction of a fraction of cases. The evidence is 19 patients, of whom about a third responded.
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.
Relacorilant kept blood pressure under control when patients who had responded were kept on it rather than switched to placebo. The pivotal trial randomised just 62 people.
reSET, Somryst and EndeavorRx cleared a real regulatory bar, on real trial data. The pivotal ADHD game moved an attention score by 0.88 of a point. Clearance is not the obstacle the category keeps hitting — payment is.
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 FDA cleared it to sort one rhythm from one other. It cannot detect a heart attack, and about one reading in eight comes back inconclusive.
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-cleared in September 2025, the feature notifies fewer than half of people with hypertension in Apple's own validation. Hypertension specialists warn the bigger risk is false reassurance.
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.
The proposed Nutrition Info box would rate saturated fat, sodium and added sugars on the front of most packaged foods. The strongest real-world evidence is for blunter warning labels.
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.
FDA-cleared in September 2024, the feature caught 89% of severe obstructive sleep apnea in Apple's validation but 43% of moderate cases. It is a nudge toward testing, not a test.