For how we live.
FDA approvals, rejections, and the filings calendar.
A 411,000-patient claims study found adults on GLP-1 drugs who started oxycodone had more severe constipation and bowel obstruction at 30 days than those starting hydrocodone or tramadol.
STAREE randomised 9,971 Australians aged 70 and over to atorvastatin or placebo. Cardiovascular events fell by 30%. Death, dementia and persistent disability, taken together, did not move.
In 4,868 clozapine users followed to 2023, excess neutropenia risk concentrated in the first 18 weeks and converged with other antipsychotics by around two years.
Matched against DPP-4 inhibitors, GLP-1 users had slightly more diabetic retinopathy and more retinopathy procedures. Vision impairment and blindness did not differ — and the coding for those is poor.
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.
Post-bariatric hypoglycemia hits roughly 1 in 12 gastric bypass patients with sudden blood sugar crashes. Avexitide cut severe events by 55% against placebo.
PBAC recommended subsidized listing in November 2025 for adults with obesity and a history of heart attack or stroke. Price negotiations with Novo Nordisk had not concluded.
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.
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.
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.
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.
The VEMORA trial randomized 23 women with genitourinary symptoms. Vaginal estrogen improved dryness and pain scores more than Replens, with blood estrogen staying low.
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.
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.
Lilly's oral GLP-1 pill actually lowered liver enzymes on average, and its rate of serious liver-injury criteria matched placebo exactly — six cases in each group, none attributable to the drug.
SYNCHRONIZE-MASLD reports 84.2% of survodutide patients hitting a 30% cut in liver fat at 48 weeks. The trial measured fat on MRI, not fibrosis on biopsy — which is where the harder question still sits.
Anxiety, quality of life and PTSD symptoms all improved after a single dose in this 15-person trial. Once researchers accounted for depression improvement, those effects mostly disappeared.
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.
By the study's end, 70% had scores low enough to be considered near-resolution. There was no placebo arm — every participant knew what they'd received.
A five-year FAERS analysis found both semaglutide and tirzepatide carry disproportionate ketoacidosis signals in people without diabetes, with roughly three-quarters of reported cases requiring hospitalization.
ATTAIN-MAINTAIN tested orforglipron as a maintenance therapy for people who'd already lost weight on tirzepatide or semaglutide. Those on placebo regained roughly half of what the pill preserved.
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.
No medication has proven effective for cocaine use disorder. A single psilocybin dose, paired with therapy, produced more abstinent days and a longer time to relapse than an active placebo.
In 35 patients with recurrent major depression, psilocybin beat an active placebo through day 42. On self-reported measures the effect lingered further, but the trial's primary endpoint showed no difference at 365 days.
TSND-201 improved PTSD severity, disability, and depression scores over placebo in 65 participants — delivered as an oral dose with monitoring but no formal psychotherapy alongside it.
Semaglutide showed a sixfold reporting signal for polycystic ovary syndrome and a smaller but real alopecia signal. Dulaglutide and tirzepatide showed lower or no signal for the same reproductive events.
No study has directly compared injectable tirzepatide with the new high-dose oral semaglutide pill. A statistical technique that adjusts across two separate trials estimates the gap.
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.
The open-label pilot tested a specific worry in psychedelic research — that borderline personality disorder blunts response to psilocybin for depression. In this small sample, it didn't.
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.
Both drugs suppress ovarian and testicular hormone production, but two decades of FDA safety reports show leuprolide skewing toward reproductive and cancer-related signals, goserelin toward endocrine ones.
A single-clinic retrospective study in Istanbul followed patients on all three drugs for 36 weeks. The ranking matches what randomized trials have shown — with liraglutide the least tolerated of the three.
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.
Most psychedelic depression trials require patients to come off antidepressants first. This one deliberately didn't — and found intranasal 5-MeO-DMT tolerable and encouraging in patients who stayed on their SSRI.
Up to eight sessions of psilocybin, layered onto a small randomized comparison against an active placebo, produced a 73% response rate by the end of treatment. The trial was designed to test safety first.
Six months out, 40.5% of smokers given one high dose of psilocybin plus therapy stayed abstinent, versus 10% on the nicotine patch plus the same therapy. The trial ran 82 people.
A 230-patient survey from one US diabetes center found symptomatic hypoglycemia more than twice as common with adjunctive tirzepatide as with semaglutide, though GI side effects were similar between the two.
Bimagrumab targets fat, not appetite. Paired with semaglutide in 507 adults with obesity, the combination out-performed either drug alone at 48 weeks — with its own separate set of side effects.
ACHIEVE-3 randomised 1,698 people to orforglipron or oral semaglutide for 52 weeks. Orforglipron cut HbA1c more at every dose comparison — and produced more side effects and more dropouts.
An individual-participant meta-analysis of 123,940 people in 19 double-blind trials tested 66 label-listed harms. Four survived correction — none of them the ones patients hear about most.
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.
Narsoplimab clears the FDA on a single-arm study of 28 adults plus 19 patients from an expanded access programme. Sixty-one per cent responded. Seven per cent had a fatal adverse reaction.
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.
TRIUMPH-4 tested retatrutide in 445 adults with obesity and knee osteoarthritis. The weight numbers are striking. So are the discontinuation numbers sitting beside them.
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.
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.
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.
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.
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.
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.
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.
Dapagliflozin beat placebo on liver histology over 48 weeks in six Chinese hospitals. Weeks later, European regulators recommended the first purpose-built drug for the same disease.
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.
The guidance is built on one negative instruction: do not stop abruptly in patients likely to be physically dependent. Hong Kong records show the sharpest prescribing rise in 18-to-25-year-olds.