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HM15421/GC1134A could become the first subcutaneous enzyme replacement therapy for Fabry disease, with BioMarin paying $70 million upfront.

The IL-23p19 inhibitor tildrakizumab becomes the third drug in its class approved for psoriatic arthritis, and the only one given exclusively by a healthcare provider.

In the final part of a three-part interview, Anurag Rathore, PhD, professor of chemical engineering at IIT Delhi, explains how his team has cut monoclonal antibody costs toward $10 per gram and why process intensification will spread one unit operation at a time.

As part of BioPharm International’s AAPS PharmSci 360 2026 coverage, Nanoform’s Chris Worrall explains why stability and viscosity have kept antibody formulations below 200 mg/mL, and how a low-temperature particle engineering process and non-aqueous suspensions could support ultra-high concentrations.

DAX-044 aims to confine IL-12 activity to tumors and avoid the toxicity that has limited IL-12 therapy, with phase 1 testing expected in 2027.

Updated phase 2 IOV-LUN-202 data show Iovance’s TIL cell therapy lifileucel produced a 24.6% response rate in previously treated non-squamous metastatic NSCLC, rising to 52.0% in KRAS and HER2 wild-type patients, as the company launches a biomarker-enriched registrational cohort.

The proposed FDA guidance would let sponsors add patient-specific gene editing variants to approved BLAs via in vitro data, with comments due November 27, 2026.

In the 80-week phase 3 TRANSCEND-T2D-2 trial in adults with type 2 diabetes, Eli Lilly’s GIP/GLP-1/glucagon triple agonist retatrutide lowered A1C by 2.2% and body weight by up to 20.9%, compared with 1.8% and 9.4% with Ozempic 2 mg.

Genmab’s petosemtamab plus pembrolizumab cuts the risk of death by 50% in phase 3 head and neck cancer, AbbVie submits a BLA for etentamig in relapsed or refractory multiple myeloma, and Benitec reports interim data for BB-301 gene therapy in OPMD-related dysphagia.

The EGFR×LGR5 bispecific antibody met both primary endpoints, overall survival and objective response rate, at the first interim analysis of LiGeR-HN1 in first-line PD-L1-positive recurrent or metastatic head and neck cancer.

Catalent Pharma Solutions's Dr Karunakar Sukuru explains how peptide potency, dose, and patient needs guide the choice between softgel and sublingual dosage forms.

Long-term phase 2 data presented at ESMO 2026 show 3SBio’s tivunatamig plus chemotherapy extended progression-free survival vs tislelizumab plus chemotherapy in squamous and non-squamous NSCLC.

All 9 patients treated with BB-301 gene therapy met formal response criteria for improved swallowing in an ongoing OPMD trial.