For how we live.
The FDA, the CDC, the courts, coverage, and what things cost.
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.
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.'
A proposed rule would cut the Part D generic copay from $1 to $0 for the lowest-income dual eligibles in 2028, tighten Medicare Advantage directory accuracy, and add PBM transparency rules. Comments close 15 December.
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.
A new 30-day order under the Public Health Service Act continues suspending the entry of certain travellers recently in DR Congo, Uganda or South Sudan. It runs through 10 November; comments close 30 October.
The government is gathering evidence to build step-count and muscle-strengthening guidance into the Physical Activity Guidelines for Americans, a supplement to the 2018 edition. Written comments close 12 November 2026.
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.
A proposed rule would push several compliance dates under the 2024 trichloroethylene risk rule to 31 December 2027, giving processors and refrigerant makers more time to drop the solvent. Comments close 13 November.
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.
A notice sets out how the agency intends to designate every US area for the 9.0 microgram 2024 fine-particle standard. Comments close 5 November; a court has ordered final designations by 6 February 2027.
A CMS and CDC proposed rule would codify pandemic-era remote review of digital lab data, allow digital images in gynaecologic cytology proficiency testing, and ease 2024 staffing rules. Comments close 7 December.
A tri-agency final rule, effective 7 December, overhauls the machine-readable price files insurers must post and requires cost estimates by phone. The changes apply to plan years from 1 January 2027.
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 draft NIH policy out for comment would require researchers to share plain-language summary results with clinical research participants for all NIH-supported studies, unless justifiably not appropriate.
HRSA has finalised eligibility guidelines for its Living Organ Donation Reimbursement Program under the HOLD Act, which bars considering the recipient's income. Eligibility now turns on the donor's own income.
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.
The final FY2027 rule lifts the federal per diem base rate to $912.40 and the electroconvulsive-therapy rate to $688.59 from 1 October, adds a standardised patient-assessment tool, and drops two quality measures.
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.
A mandatory CMS payment model finalised 2 October recalculates inflation rebates for certain physician-administered drugs against an international benchmark, and can cut a patient's coinsurance to 10%.
A final action moves the Serious-area deadline for the Los Angeles-South Coast fine-particle area from December 2025 to December 2030, after California showed on-time attainment was impracticable. Effective 2 November.
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.
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.
An interim final rule lets HHS freeze federal-marketplace registration for agents and brokers without a current plan-year agreement. CMS imposed the pause immediately; it runs until 1 February 2027.
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.
Housing is a health exposure. The mortality data on homelessness are among the starkest in medicine — and a large share of the deaths are from causes health care can treat.
The evidence that recessions and job loss kill is stronger than it looks. Three landmark studies quantify the mortality signal — and where it stops being causal.
Federal statistics put 18.3 million households short of food last year. A 57,404-person cohort links lower food security to higher premature mortality and years of lost life expectancy.
CMS took comment through 18 September 2026 on draft rules for how manufacturers must deliver negotiated drug prices in 2028. The mechanism is a refund owed within 14 days, not a lower shelf price.
The agency is repealing the carbon-capture-based standards at the heart of the 2024 rule, saying compliance-cost savings outweigh the emission cuts. It takes effect on 16 November 2026.
The RAPID pathway would issue a proposed national coverage decision the day a device clears the FDA, cutting a process that normally runs 9 to 12 months. The trade-off is evidence.
A controlled study tied Scotland's minimum unit price to a 13.4% fall in deaths wholly caused by alcohol, largest in the most deprived areas. The effect on hospital admissions was smaller and not significant.
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.
The federal program enrols nearly 140,000 responders and survivors, most certified for a 9/11-related illness. Cohort data show a heavy, still-growing burden — and hint the program itself lowers mortality.
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.
The phrase is used loosely and argued about fiercely. At its core is a genuine dilemma: experiments that make a pathogen more dangerous can also be the ones that warn us fastest.
A, B, C, D and I are not school marks. They encode how strong the evidence is, whether to screen at all — and in the US, whether insurance has to pay for it.
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.
The Vaccine Integrity Project, formed in 2025 amid disruptions to the CDC's immunisation advisory committee, sets out its process for reviewing 2026–2027 respiratory-season vaccines.
The patented method uses mifepristone for hypercortisolism-related insulin resistance, with dosing capped to avoid over-activating the stress-hormone axis. The public can object before the deal closes.
JAMA published paired systematic reviews for the coming respiratory season. Both found vaccines reduced hospitalisation across age groups, with no new safety signals, though protection wanes over time.
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.
A Federal Register notice opens a five-day comment window in September. The stated goal is to realign clinical operations across the institute and align with Presidential priorities.
The list price is the sticker; the net price is what the maker keeps after rebates. For one insulin, list rose 27% over five years as the net price fell 10%. Who you are decides which you pay.
The 2012 safe harbour for 3Rs data was barely used. The replacement is a voluntary pilot that takes submissions independently of a marketing application, running until the third quarter of 2027.
A review by the country's Public Health Authority credits enforcement and awareness campaigns for falls in crashes, deaths and injuries from 2013 to 2023 — while naming what still holds the Vision 2030 target back.
The ESC released updated heart failure guidance plus first-ever guidelines on cardiac rehabilitation and on cardiovascular disease with chronic kidney disease. All three sit behind a paywall.
A study of Current Population Survey data finds 19.8% of likely expansion enrollees sit near the 20-hour threshold or report variable hours. Women are at higher risk than men.
Americans owed about $140 billion in medical bills in collections. But two randomized experiments that relieved debt found no average effect on credit, financial distress or mental health.
Across 26 states, expansion raised the Medicaid-paid share of deliveries by 5.2% and changed the severe maternal morbidity rate by 0.02% — an interval that includes zero in both directions.
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.
Pharmacy benefit managers sit between you, your insurer and the pharmacy. The three largest process nearly 80% of US prescriptions, and a federal regulator says the structure can raise costs.
Seventy-seven thousand fewer children got PEPFAR-supported HIV treatment in 2025 than the year before. UNAIDS warns permanent cuts could mean millions of additional infections and deaths by 2029.
The administration wanted to consolidate NIH's 27 institutes into eight and cut roughly $18 billion from its budget. The signed law does neither.
England's A&E departments handled 2.5 million attendances in July alone. Nursing staff say wards without air conditioning are becoming an occupational-safety problem, not just a patient-comfort one.
The pandemic-era rules letting Medicare patients see a doctor from home, anywhere in the country, are now locked in through the end of 2027 — the longest extension since they were created.
The public comment window just closed on a proposal that would govern how up to 20 high-cost drugs a year get their Medicare prices negotiated, starting with prices that take effect in 2029.
Twenty-five states wanted the rule paused while they sued. The judge said the 90% federal reimbursement for setup costs undercut their case for emergency relief — not that their underlying legal argument was wrong.
The court didn't strike down Idaho's ban. It said the state can't prosecute doctors for abortions performed to protect a patient's health, not just her life. Idaho is appealing.
The administration wants pharmaceutical manufacturing back on US soil. The runway it's offering is shorter than the time it typically takes to build and validate a new drug plant.
HHS Secretary Kennedy held the money over Gavi's use of a mercury-based preservative most safety reviews call harmless in trace amounts. Gavi says it was already phasing the ingredient out.
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.
Since 2021, hospitals must post the rates they negotiate with each insurer. The data confirms the same procedure at the same hospital varies widely by which insurer is paying.
Physician surveys report delays and abandoned treatment; those are self-reported. A harder number: a federal audit found 13% of Medicare Advantage denials met Medicare's own coverage rules.
US guidance recommends mammography from 40. A Canadian review of the same randomised evidence put the benefit at 0.27 fewer breast cancer deaths per 1,000 women aged 40-49 over ten years.
Medicare's cap is statutory; the commercial version is a voluntary manufacturer promise with conditions. Before the caps, 1.3 million adults rationed insulin because of cost.
The advisory committee that shaped U.S. immunization policy for decades was replaced, then bypassed. In March a judge stayed the result.
The prices apply only to 10 drugs, only in Medicare, and only from January 2026. Here is exactly which drugs, by how much, and who actually sees the difference.
The final rule raises operating payment rates 2.4% and directs about $2.9 billion more to acute-care hospitals in the year from 1 October 2026. Hospital groups called the increase too low.
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.
A study of 1,331 physicians put violence ahead of pay. Of 32 doctors who had already emigrated, two were considering coming back — and none of the women were.
Across all drugs, US prices are 2.78 times those in 33 other wealthy countries. The gap is not that Americans use more medicine — it is that no one sets the launch price.
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.
A first consolidated audit of PBS and PHARMAC cardiovascular listings from 2023 to 2025 finds a widening access gap between two neighbouring countries with similar disease burdens.
The CHMP's June meeting recommended pulling avacopan from the EU market on data-integrity grounds, refused three cell and biological therapies, and reversed itself on a Rett syndrome drug it had earlier rejected.
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.
The appeal is moving on an expedited track, with a status report due this month. But CIDRAP's vaccine-policy trackers make a pointed argument: a working committee could exist right now, if HHS chose to seat one.
Coverage for adult vaccines like pneumococcal sits around a third of those eligible, far below targets. The evidence points less to refusal than to cost, insurance and the absence of a routine adult-vaccine visit.
A new administration analysis estimates 2.9 million people were removed from ACA exchange plans as improperly or fraudulently enrolled — and that 2.6 million more remain.
The committee's founding document now asks for a 'balanced range' of expertise rather than vaccine-specific knowledge, and adds review of non-vaccine alternatives to its mandate.
Twenty-two years of national data show income-related inequities in care use narrowing, and copayment increases for higher earners not reversing that. Services carrying extra user charges are the outlier.
A comparison of FDA, EMA and ANVISA decisions from 2020 to 2024 finds Brazilian approvals arriving about a year later. A second study clocks the wait for public-system financing in years, not months.
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.
The ESC Atlas reports 68 million disability-adjusted life years and more than three million cardiovascular deaths a year, with middle-income countries carrying roughly double the mortality of high-income ones.
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.
Developing countries paid a record US$1.4 trillion in debt service in 2023. A 105-country study finds debt servicing nudges the health-financing mix toward out-of-pocket, but only modestly.
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.
PHARMAC's October 2024 decision left one brand's sensors unfunded, forcing a device switch. A single-centre audit of 79 children found HbA1c fell slightly — and cannot say the switch caused it.
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.
An econometric analysis of the 2019 European Health Interview Survey prices smoking-attributable inpatient and daycare hospitalisation across the EU — deliberately excluding every other kind of care.
Two vaccines cut RSV lower-respiratory illness in older adults by roughly two-thirds to four-fifths in their pivotal trials. US guidance now recommends them for everyone 75 and older and for high-risk adults from 50.
The CHMP backed tolebrutinib for non-relapsing secondary progressive multiple sclerosis, a population with no prior disability-targeting treatment. The trial showed a 31% delay in progression.
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.
Anvisa's five new resolutions build a controlled supply chain from seed to shelf, including a regulatory sandbox for patient associations. Analysts say the framework's biggest gap is the one it did not close.
Sub-Saharan Africa received $11 billion in external assistance for community health worker programmes over two decades. More than three-quarters went to single-disease work, and the annual financing gap never closed.
The European Medicines Agency's March meeting produced five positive opinions, three of them for orphan-designated cancer and rare-disease treatments already available in some other markets.
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.
Judge Brian Murphy found the government likely broke two federal laws when it bypassed ACIP and replaced its members. The ruling reverts the childhood schedule and cancels this week's ACIP meeting.
WHO updated all three components for the 2026-2027 northern hemisphere season after subclade K dominated globally, and recommended a new candidate vaccine virus for an H9N2 avian strain.
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 objection turns on a no-treatment arm. WHO says placebo or no-treatment vaccine trials are acceptable only where no proven intervention exists, and here one does.
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.
The American Academy of Pediatrics' 2026 schedule covers 18 diseases and carries 12 outside endorsements. The federal schedule signed three weeks earlier lists 11 vaccines for all children.
Large taxed beverage sales fell 24 to 31 percent under the tax. In the period after repeal they remained 13 to 24 percent below pre-tax levels — and prices stayed elevated too.
Eleven vaccines remain recommended for all children. The rest move to risk-based or shared-decision categories, on the strength of a comparison with 20 other countries.
Neither the Democratic extension nor the Republican alternative cleared the 60-vote threshold. KFF puts the average out-of-pocket premium increase at 114%.
A federal recommendation is load-bearing for insurance coverage, the Vaccines for Children programme, and school requirements. States have started building alternatives to all three.
The 5 December directive tells HHS and the CDC to compare the American childhood schedule with those of other wealthy nations, using a count of diseases as its benchmark.
ACIP replaced a recommendation in place since 1991 with individual decision-making for babies born to mothers who test negative. The CDC has not yet adopted it.
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.
The CHMP's November meeting produced ten positive opinions. Two of them — teplizumab and a Telethon-sponsored gene therapy — address conditions the EU has had no authorised treatment for.
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.
Two trials showed more deaths on voxelotor than placebo. The registry data that triggered the 2024 precautionary suspension did not confirm the original signal — the trials did something worse.
Brensocatib cleared CHMP on an accelerated timetable with a 19.4% cut in exacerbation rate. The same October meeting issued a negative opinion on belumosudil and kept a sickle cell drug suspended.
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.
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.
Seven of those nine were denosumab. The committee's September opinions also covered an RSV antibody for infants, a first EU treatment for IgG4-related disease, and four withdrawn applications.
The recommendation covers people weighing at least 35 kg and rests on two trials in which lenacapavir cut HIV infections by 100% and 96% against background incidence.
The committee meets 18-19 September on COVID-19, hepatitis B and MMRV vaccines. RSV was dropped two days before. Adopted recommendations carry insurance and Vaccines for Children consequences.
IHME's annual accounting puts development assistance for health at less than half its 2021 peak, with no recovery forecast to 2030. A companion model estimates what that means for tuberculosis.
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.
A Federal Register notice on 9 June listed eleven vaccine topics and ten scheduled votes over three days. An amended notice on 24 June listed seven topics, three votes and two days.
The World Health Assembly approved US$6.2 billion for 2026-2027 after trimming the base to US$4.27 billion. The notified US withdrawal cut the assessments available for it by US$311.1 million.
For the first time, Part D limits annual out-of-pocket drug spending to $2,000, with an option to pay it in monthly installments. Over a million heart patients alone were spending more.