At AAO 2025, Genentech reported that vamikibart, a first-in-class IL-6–targeted antibody, led to rapid improvements in visual acuity and macular thickness in patients with uveitic macular edema, supporting its potential as a non-steroid treatment option.
At ESMO 2025, AstraZeneca reported that Imfinzi plus BCG therapy reduced the risk of recurrence or death by 32% in patients with high-risk non-muscle-invasive bladder cancer, marking a potential new standard in early-stage disease.
At ESMO 2025, Eli Lilly’s Verzenio and Novartis’ Kisqali both demonstrated durable efficacy in hormone receptor-positive, HER2-negative early breast cancer, with improvements in overall and invasive disease-free survival.
New results from the Phase III MATTERHORN trial show AstraZeneca’s Imfinzi combination reduced the risk of death by 22% versus chemotherapy alone, marking a major advance for patients with resectable gastric and gastroesophageal junction cancers.
Praxis Precision Medicines’ Essential3 program met all primary and key secondary endpoints, with ulixacaltamide showing significant improvements in tremor control and daily functioning in patients with essential tremor.
Eli Lilly’s oral GLP-1 therapy, orforglipron, met all primary and key secondary endpoints in the Phase III ACHIEVE-2 and ACHIEVE-5 studies, showing significant A1C reduction, weight loss, and cardiovascular benefits compared to both dapagliflozin and placebo.
The FDA has approved Eli Lilly’s Inluriyo (imlunestrant), the first oral estrogen receptor antagonist for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, based on Phase III EMBER-3 results showing a 38% reduction in risk of progression or death versus endocrine therapy.
Based on Phase III DESTINY-Breast09 results showing a 44% reduction in risk of progression or death versus standard therapy, AstraZeneca and Daiichi Sankyo’s Enhertu-pertuzumab combination could mark the first major advance in this treatment setting in over a decade.
In Stage 1 of the Phase II LANTIC study, Ipsen’s novel recombinant molecule IPN10200 met its primary endpoint with significant improvement at week 4 versus placebo and showed longer duration of effect versus Dysport, with most patients maintaining meaningful response at week 24.
In this video interview, Ananth Kadambi, VP of real-world evidence and modeling solutions at Certara, outlines how FDA’s emphasis on overall survival in oncology trials requires stronger safety monitoring, subgroup planning, and patient tracking.
Real-world data from more than 58,000 older adults with type 2 diabetes and cardiovascular disease demonstrate that semaglutide lowers the risk of major adverse cardiovascular events, reinforcing its differentiated profile among GLP-1 receptor agonists.
An interim analysis of the TULIP-SC trial found that weekly subcutaneous delivery of Saphnelo significantly reduced disease activity in patients with moderate to severe SLE, offering a more convenient option with a safety profile consistent with IV administration.
Full patient enrollment in REVEAL-1 (NCT06812325) and REVEAL-2 (NCT06625398) trials mark a key milestone for VRDN-003, Viridian’s promising new therapy for thyroid eye disease.
Preliminary Phase IV trial results show that Moderna’s 2025–2026 Spikevax formula boosted neutralizing antibodies more than eight-fold in high-risk adults and older populations against COVID-19.
The Phase II trial (NCT07145229) will evaluate the safety, efficacy, and pharmacodynamics of ABP-745 compared with placebo and standard colchicine therapy in over 200 patients with acute gout flares.
The IDeate-Lung01 trial showed a 48% confirmed response rate with Merck’s B7-H3 directed antibody-drug conjugate in previously treated extensive-stage small cell lung cancer, with durable benefit observed across second- and later-line patients, including those with brain metastases.
Interim results from the ongoing Phase IV LOTUS trial showed that Daybue delivered sustained behavioral improvements and manageable gastrointestinal outcomes in Rett syndrome patients over one year.
Results from the Phase III STRIDE-13 trial (NCT06177912) showed that Merck’s Capvaxive was noninferior to PPSV23 in children and adolescents aged 2 to <18 years who are at increased risk of pneumococcal disease due to chronic medical conditions.
In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, explains how NIMBLE showed cemdisiran achieved strong efficacy with partial complement inhibition and reduced disease worsening compared to combination therapy.
The FDA-approved therapy is now included in National Comprehensive Cancer Network clinical guidelines as a treatment option for both pediatric and adult patients with aggressive H3 K27M-mutant diffuse gliomas, offering a new standard of care for recurrent disease.
Results from the two-year AVONELLE-X extension study (NCT04777201) and the Phase IIIb/IV SALWEEN trial showed that Roche’s Vabysmo demonstrated durable vision improvements, extended dosing potential, and reliable safety treating wet age-related macular degeneration and polypoidal choroidal vasculopathy.
In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, outlines how the Phase III NIMBLE trial showed cemdisiran improved daily living and clinical assessments in patients with generalized myasthenia gravis.
The pivotal trial showed Eli Lilly’s non-covalent BTK inhibitor pirtobrutinib significantly improved progression-free survival over bendamustine plus rituximab in untreated CLL/SLL patients, with overall survival trending in favor of Jaypirca.
Results from a Phase II trial (NCT06449209) showed that BioNTech’s and Bristol Myers Squibb’s pumitamig in combination with standard chemotherapy demonstrated encouraging anti-tumor activity in patients with extensive-stage small cell lung cancer.
Five-year results from the Phase III EMPOWER-Lung 3 trial show Libtayo combined with chemotherapy achieved a 19.4% overall survival rate versus 8.8% with chemotherapy alone, with notable benefit in squamous NSCLC patients reaching a median overall survival of 22.3 months.
