For how we live.
FDA approvals, rejections, and the filings calendar.
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.
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.
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.
In the 17,701-person E.mbrace trial in adults 60 and older, the nine-valent ExPEC9V vaccine showed 14.63% efficacy, with a confidence interval spanning zero. It stopped early for futility; development is discontinued.
In a 180-infant phase 1/2 trial, a live-attenuated intranasal RSV vaccine raised neutralising antibodies in two-thirds or more of RSV-naive babies but barely budged those already exposed. Sanofi funded the study.
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.
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.
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.
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%.
Ketamine cuts suicidal thinking fast but briefly. A 50-person trial gave low-dose buprenorphine afterward and saw the effect hold — an early, single-centre result in a high-risk group.
In a 366-child phase 2b trial, the live attenuated nasal vaccine BPZE1 raised the mucosal antibody current shots miss, and did not blunt a co-given Tdap. The maker funded the study.
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.
In a phase 2 trial in people whose hidradenitis suppurativa had already failed anti-TNF drugs, two lutikizumab doses beat placebo at 16 weeks. A third did not, and the placebo response was high.
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.
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.
Gilead's phase 3 trial in 539 patients was terminated after the CD47 antibody failed to improve remission or survival and caused more fatal adverse events than azacitidine alone.
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.
The final analysis of Roche's phase 3 trial found the anti-TIGIT antibody did not significantly extend progression-free or overall survival when added to atezolizumab in 521 patients.
VICTORY randomised 238 adults with severe burns to intravenous vitamin C or placebo. It was stopped early: 28-day mortality was 15.0% versus 7.6%, and the trial crossed a prespecified harm threshold.
REPLENISH randomised 381 patients with relapsed polymyalgia rheumatica. Sustained remission at 52 weeks reached about 41% on secukinumab versus 20.4% on placebo. Novartis funded the trial.
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.
The first randomised head-to-head trial of the two obesity drugs gave 751 adults the maximum tolerated dose of each for 72 weeks. Tirzepatide cut weight by 20.2%, semaglutide by 13.7%.
In 709 children with high-risk B-cell ALL, swapping two chemotherapy cycles for the T-cell-engaging antibody lifted four-year event-free survival to 83% from 70% and sharply cut serious infections.
Amycretin, a single molecule that activates both the GLP-1 and amylin receptors, produced up to 24.3% weight loss over 36 weeks in a 125-person study. The primary goal, though, was safety — not weight.
In ESSENCE, the first 800 patients with biopsy-confirmed fatty-liver disease were analysed at week 72. Steatohepatitis resolved in 62.9% on semaglutide versus 34.3% on placebo — an interim look at an ongoing trial.
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.
In a phase 3 trial, tambotatug pelitecan extended median survival to 13.3 months versus 9.4 on standard chemotherapy — but the trial was open-label and run entirely in China.
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.
Satralizumab reduced eye-bulging and inflammation in thyroid eye disease across the twin SatraGO phase 3 trials, but the primary proptosis endpoint reached statistical significance in only one of them.
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.
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.
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.
Rezpegaldesleukin works by expanding the immune system's regulatory T cells rather than blocking an inflammatory signal — a new mechanism for atopic dermatitis, tested so far only in a phase 2b study.
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.
A once-daily experimental pill beat placebo in a phase 3 trial and is under regulatory review — yet no study has tested its claimed edge over older dopamine agonists head-to-head.
The agency compressed review of three psychedelic therapies from a year to weeks. A first approval decision is plausible by early 2027.
Dazukibart eased skin and muscle disease within weeks and held up for nearly two years — but the trials were tiny, manufacturer-run, and the makers say a phase 3 is needed to confirm it.
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.
A randomised-withdrawal trial showed the antibody-lowering drug kept CIDP patients in remission. A 2026 extension reports lasting benefit, but with no placebo group to measure it against.
The targeted combination more than tripled progression-free survival versus placebo in iodine-refractory disease — but overall survival is not yet significant and the trial was mostly Asian.
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.
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 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.
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.
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.
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.