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Allogene's Cema-Cel Receives FDA RMAT and Fast Track Designations for First-Line LBCL Consolidation

Ocugen's OCU410 Gene Therapy Wins FDA RMAT Designation for Geographic Atrophy

FDA Questions RP1 Efficacy Ahead of Advisory Committee Vote on Melanoma Combination

Ask the Expert: Manufacturing Flexibility Is the Next Competitive Advantage

How Linker Innovation Could Shape the Next Generation of Antibody–Drug Conjugates

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Ahead of a July 29 FDA advisory committee meeting, the FDA released briefing documents disputing Capricor Therapeutics' claim that its Phase 3 HOPE-3 trial of deramiocel, a cell therapy for Duchenne muscular dystrophy cardiomyopathy, met its primary and secondary efficacy endpoints, a disagreement centered on which version of the trial's statistical analysis plan should govern the results.

AbelZeta has received FDA RMAT clearance for a registrational phase 2 trial of its bispecific CAR-T therapy, C-CAR168, in refractory lupus nephritis.

GSK will invest £400 million (US$532 million) in a new Cambridge, UK, R&D center, relocating from Stevenage amid second quarter earnings and a cost-savings plan.

Today's podcast episode highlights three stories shaping the future of antibody therapeutics, from a next-generation bispecific ADC advancing toward the clinic, to a new biologics innovation consortium in China, to a major acquisition expanding an autoimmune pipeline.

Brandon Pence, FUJIFILM Biosciences' president and chief operating officer, identifies cell consistency and viral vector capsid fill ratios as the 2 most critical unresolved hurdles in CGT manufacturing scale-up.

Veraxa Biotech has advanced its bispecific antibody-drug conjugate program VXA-222 into its next development phase after OmniAb completed discovery work under their May 2025 collaboration, creating a dual-antigen "AND-gate" candidate designed to improve precision in solid tumor treatment.

Harbour BioMed and Sinopharm have formed a strategic Innovation Consortium to co-develop biologics in oncology and immune-mediated inflammatory disease.

argenx will acquire Forte Biosciences for $2.2 billion, which will add first-in-class anti-CD122 antibody, FB102, to its immunology pipeline.

As biopharmaceutical manufacturing becomes increasingly automated, real-time analytical data is poised to transform how manufacturers monitor processes, make decisions, and optimize production. Bryan Hassell, founder and CEO of Nirrin Technologies, discusses why trusted, continuous measurements will be essential to the next generation of digital biomanufacturing.

Arrowhead's plozasiran cut triglycerides up to 81% and pancreatitis events up to 100% in phase 3 trials, Greenwich LifeSciences expanded its GP2 breast cancer vaccine trial into the UK, and Ipsen completed its acquisition of Memo Therapeutics to add the first-in-class antibody potravitug to its rare disease pipeline.

Generare CEO Guillaume Vandenesch explains that genomics and synthetic biology are positioning natural molecule discovery as a leading small molecule modality for the 21st century.

Johnson & Johnson reported that phase 3 MonumenTAL-6 data show Tecvayli plus Talvey cut the risk of progression or death by 89% in relapsed/refractory multiple myeloma.

A Phase 1 trial of DYP688, a first-in-class antibody-drug conjugate targeting the Gq/11 pathway, showed disease control in more than 80% of patients with metastatic uveal melanoma and was well tolerated, according to findings published in Nature Medicine, even after Novartis halted the drug's development.

A new peer-reviewed publication in Clinical Cancer Research details preclinical data for Pheast Therapeutics' PHST001, an anti-CD24 monoclonal antibody, showing anti-tumor activity across six solid tumor types and enhanced effects when combined with chemotherapy, radiotherapy, and antibody-drug conjugates.

Sanofi announced it has discontinued amlitelimab in atopic dermatitis, forgoing global regulatory submissions despite positive long-term phase 3 data.






















