Development

The European Commission has approved Tepkinly in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma after at least two prior systemic therapies, based on Phase 3 EPCORE FL-1 data showing a 79% reduction in risk of disease progression or death — marking the first bispecific antibody-based combination regimen approved in Europe for this indication.

The FDA has approved a label expansion for Casgevy, the first CRISPR-based gene therapy, lowering the eligible age from 12 to 2 years in sickle cell disease — a move that significantly broadens the potential patient population and marks another milestone in the clinical maturation of CRISPR-based genomic medicine.

Three-year follow-up data from Agenus' Phase 2 trial of botensilimab plus balstilimab in refractory microsatellite-stable metastatic colorectal cancer show a 33% overall survival rate at three years — with evidence of a plateau on the Kaplan-Meier curve beyond two years — representing an unprecedented durability signal in a tumor type historically resistant to immune checkpoint therapy.

CNS monoclonal antibody therapies demand rigorous screening and monitoring to ensure patient safety in MS, NMOSD, and Alzheimer disease.

92Bio, Inc. has dosed the first patient in a Phase 1 trial of NTB-928, a fully human bispecific T-cell engager targeting FOLR1 and CD3, designed to selectively kill FOLR1-overexpressing ovarian cancer cells while sparing normal tissue — addressing a key limitation of prior FOLR1-directed therapies in platinum-resistant ovarian cancer.

BIO 2026 highlighted biotech's resurgence through M&A dealmaking, CDMO diversification, and renewed investor confidence in biopharma development.

A phase 2 controlled human infection trial has found that two doses of WRSs2, a live-attenuated oral vaccine candidate against Shigella sonnei, achieved 89% protection — the highest efficacy reported for any Shigella vaccine candidate — with no serious adverse events, advancing a century-long quest for a licensed vaccine against the diarrheal pathogen.

Speaking at BIO 2026, Kasper Øland, Samsung Biologics' vice president of sales execution, emphasizes how complex molecules now exceed 55% of the company’s pipeline as biotechs demand faster, more flexible CDMO partnerships.

FDA reported that the PRECISION-T trial showed 78% chronic GVHD-free survival at 1 year versus 38.4% with standard transplant and granted the approval to Orca Biosystems, making the therapy the first Treg cell–based therapy in blood cancers.

At BIO International Convention 2026, Sara-Jane Demy discusses improving biotech investment, renewed NIH support for emerging companies, and why capital access remains one of the industry's biggest priorities.

The European Investment Bank-backed investment establishes a new single-use GMP facility with which Icosagen can support complex protein therapeutics from early discovery through phase 1/2 clinical manufacturing.

The FDA has accepted Sarepta's supplemental New Drug Applications seeking to convert casimersen (Amondys 45) and golodirsen (Vyondys 53) from accelerated to traditional approval in Duchenne muscular dystrophy, with a PDUFA target action date of February 28, 2027, backed by ESSENCE confirmatory trial data and years of real-world evidence.

The FDA has granted priority review to Genentech's sBLA for Enspryng (satralizumab), an IL-6 receptor-targeting monoclonal antibody, as a potential first at-home subcutaneous treatment for thyroid eye disease, based on Phase III SatraGO data showing significant proptosis reduction, with an FDA decision expected by October 15, 2026.

ADC Therapeutics has completed enrollment of 100 patients in the Phase 1b LOTIS-7 trial evaluating loncastuximab tesirine-lpyl plus the bispecific antibody glofitamab in relapsed/refractory diffuse large B-cell lymphoma, with full data expected in Q4 2026 following earlier results showing an 89.8% overall response rate.

From his presentation at BIO 2026, Infinimune CEO Dr Wyatt McDonnell makes the case for how human-derived antibodies and human-trained AI models eliminate species translation failure and compress time to IND.

52-abstract package includes first reported real-world at-home subcutaneous administration data and phase 2 combination findings with anti-tau antibody.

Dr Wyatt McDonnell, Infinimune CEO, details how FDA's non-animal model guidances are reshaping non-clinical safety strategies for mAb developers in his talk at BIO 2026.

New York-based biotech enters Nasdaq through JATT II merger, betting IL-13 × IL-18 dual blockade can break the efficacy ceiling in I&I

Lumvoa gains FDA approval for thyroid eye disease, adding an IGF-1R antagonist supported by phase 3 active and chronic TED trials.

AI models can deliver transformative insights into drug manufacturing, but only when fed complete, traceable, and representative datasets.

Mediar Therapeutics has dosed the first participants in a Phase 1 trial evaluating MTX-439, a first-in-class monoclonal antibody targeting SMOC2 for fibrosis associated with chronic kidney disease. The study marks the company's third anti-fibrotic program to enter clinical development and highlights growing interest in fibrosis-directed biologics.

China's National Medical Products Administration has approved izalontamab brengitecan (iza-bren) for recurrent or metastatic nasopharyngeal carcinoma, making it the first bispecific antibody-drug conjugate to receive regulatory approval anywhere in the world.

AbbVie has entered a definitive agreement to acquire Apogee Therapeutics for $10.9 billion, adding zumilokibart, a subcutaneous half-life extended IL-13 monoclonal antibody in Phase 3 development for atopic dermatitis, asthma, and eosinophilic esophagitis.

Innovent Biologics has dosed the first patient in TriadicMM-1, a pivotal phase 3 trial evaluating IBI3003, a GPRC5D/BCMA/CD3 trispecific antibody, for relapsed or refractory multiple myeloma — marking the second trispecific antibody globally to reach pivotal phase 3 development in this setting and the first with independent intellectual property rights in China.

Newly launched Bionyra Pharma has raised $165 million in Series A financing and secured exclusive global rights to two TL1A-targeting biologics from China's TrueLab Biopharmaceutical — an anti-TL1A monoclonal antibody and a TL1A×IL-23p19 bispecific antibody — in a deal worth up to $985 million, positioning the company to compete in an IBD drug class already drawing attention from Merck, Roche, and the Sanofi/Teva partnership.