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The FDA has accepted Roche's supplemental BLA for a chemotherapy-free combination of mosunetuzumab (Lunsumio VELO) and polatuzumab vedotin (Polivy) in adults with relapsed or refractory large B-cell lymphoma, based on Phase 3 SUNMO trial data showing a 59% reduction in the risk of disease progression or death compared to standard salvage chemotherapy.

The supplemental approval is based on immunogenicity data from the STRIDE-13 phase 3 trial and, according to Merck, makes the vaccine the only one of its type specifically indicated for this at-risk pediatric population in the United States.

Moderna's mFLUSIVA (mRNA-1010) faces an FDA advisory committee vote on June 18 — a pivotal step for the first mRNA-based seasonal influenza vaccine to seek US licensure, following a turbulent regulatory path that began with an unprecedented refusal-to-file decision earlier this year.

The launch window isn't just getting shorter, it’s moving earlier. Here’s how emerging biopharma companies can prepare for commercialization before approval arrives.

The company reported that phase I data show approximately 40% of patients remained cancer-free at 10 years, while 2 phase 2 trials are ongoing.

LG AI Research and D&D Pharmatech have launched a collaboration aimed at developing next-generation oral peptide therapeutics by combining artificial intelligence-driven molecular design with peptide formulation and development expertise.

Jazz Pharmaceuticals and AbCellera have entered a research collaboration to discover and develop next-generation multispecific T-cell engaging antibodies for gastrointestinal cancers and other solid tumors, with the agreement potentially valued at up to $792 million per program.

Collapsing entry prices and a thickening field of competitors have recast process intensification for biosimilars as a question of commercial survival through speed and agility.

Cytiva’s Pierre-Alain Ruffieux discusses standardization, regionalization, talent gaps, and regulatory pathways shaping advanced biomanufacturing’s future ahead of BIO 2026.

Bambusa Therapeutics reported positive preliminary phase 1 multiple ascending dose data for BBT002, a bispecific antibody targeting IL-4Rα and IL-5. The investigational therapy demonstrated sustained biomarker suppression, a favorable safety profile, and a half-life supporting extended dosing intervals.

The company reported that all three participants in the 3 µg/kg dose cohort achieved a ≥25% SALT score reduction following single-dose subcutaneous administration, with dose escalation ongoing toward a recommended phase 2 dose.

Interim phase 1 data show CTIM-76 achieved a 29% confirmed overall response rate in heavily pretreated patients with platinum-resistant ovarian cancer, while demonstrating a favorable safety profile and low rates of cytokine release syndrome.

Johnson & Johnson reported that the MonumenTAL-3 trial showed 24-month progression-free survival up to 81.3% and overall survival up to 89.2% with the GPRC5D bispecific combination versus standard of care.