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In a 98-patient French trial, six-monthly rituximab did not extend remission beyond daily azathioprine in this rare eosinophilic vasculitis — and recipients had more severe infections.
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.
In a 348-patient trial, patients in sustained low disease activity who stepped down their biologic kept it almost as often as those who stayed on full dose over 24 weeks — but some measures still favoured continuing.
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.
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.
In the GSK-funded phase 3 MATINEE trial, the anti-IL-5 antibody lowered moderate or severe exacerbations from 1.01 to 0.80 a year — but symptom and quality-of-life endpoints showed no significant benefit.
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.
AMPLIFIED enriched for early rheumatoid arthritis patients thought to respond best to abatacept, then compared it head-to-head with adalimumab. At week 24 the two drugs were indistinguishable.
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.
A pooled analysis of four trials found depemokimab roughly halved exacerbations, yet it did not significantly improve asthma control or reach the threshold for a meaningful quality-of-life gain.
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 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.
In the phase 3 INDIGO trial, weekly obexelimab roughly halved the risk of a flare in this rare fibroinflammatory disease and spared patients steroids — a positive result in a condition with no approved drug.
In PHOENYCS GO, dapirolizumab pegol lifted the share of lupus patients reaching a composite response at 48 weeks to 50% from 35% on placebo — a real but modest 14.6-point gain.
Open-label follow-up of the phase 3 LUNA3 trial shows rilzabrutinib's platelet responses were durable and sometimes appeared in people who had not responded at first — but a minority reached the mark.
At one year, 79% of newly diagnosed patients given early infliximab plus an immunomodulator were in steroid-free, surgery-free remission, versus 15% treated conventionally.
Tozorakimab, which blocks interleukin-33, lowered the rate of moderate or severe COPD exacerbations by about a third against placebo, without an eosinophil requirement to qualify.
Three 2025 reviews of the same drugs reach three answers: a matched cohort finds less cardiovascular disease on biologics, a network meta-analysis flags one drug as raising events, and 43 trials find nothing.
In the two pivotal dupilumab trials, 36% to 38% reached that endpoint at 16 weeks against 8% to 10% on placebo. A 97-trial network review finds the newer drugs clustered closely together.
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 final HARMONi-A analysis reports a 2.7-month gain in median overall survival — 16.8 versus 14.1 months — for the PD-1/VEGF bispecific added to chemotherapy in a China-only phase 3 trial.
A registry snapshot of 13,455 adults measures how far the biologic era has moved severe asthma toward remission, and finds the inflammation these drugs target still detectable in most patients.
In the head-to-head OVERLORD-MS trial, 92.2% on rituximab and 94.8% on ocrelizumab had no new MRI lesions from months 6 to 24, meeting the prespecified bar for noninferiority.
In the phase 3 GCAptAIN trial the interleukin-17A blocker did not significantly beat placebo for sustained remission at one year, leaving the IL-6 inhibitor tocilizumab as the proven steroid-sparing option.
Two large trials of the anti-ST2 antibody gave discordant results: a modest signal in the phase 2b study, and a missed primary endpoint for the same dose in the confirmatory phase 3.
Cemdisiran, a gene-silencing drug given under the skin once every three months, cut daily-living scores more than placebo in antibody-positive generalised myasthenia gravis, a rare complement-driven disease.
In the open-label extension of the VIVID programme, remission rates stayed high at 104 weeks — but no placebo group ran alongside, so durability is described, not proven, against nature.
In the COSPIRIT-JIA trial, most children with two stubborn forms of juvenile idiopathic arthritis responded to ixekizumab by week 16 — but the main result had no control group.
In the ALLEGORY trial, 76.7% of patients with active SLE reached the SRI-4 response at 52 weeks on the B-cell–depleting antibody versus 53.5% on placebo, extending a drug already cleared for lupus nephritis.
Efimosfermin, an FGF21 analogue given every four weeks, was well tolerated over 24 weeks in 84 patients with fatty-liver disease — but this trial was designed to test safety, not whether it heals the liver.
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.