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Litifilimab extended skin responses through 52 weeks in phase 2 AMETHYST data in cutaneous lupus erythematosus, with phase 3 results expected in 2027.

Manufacturing remediation, not efficacy or safety data, is delaying US approval of Novo's h+emophilia A therapy denecimig.

Doubled drug substance capacity at Alvotech's Reykjavik, Iceland, site aims to secure steady US supply of the Humira biosimilar Simlandi.

The glucagon/GLP-1 dual agonist hit both weight loss endpoints in phase 3, though gastrointestinal discontinuations and competitor data temper the readout.

CaseBioscience joins an ARPA-H effort to develop room-temperature cell therapy preservation, Novartis licenses an mRNA-encoded T-cell engager from Abogen, and AstraZeneca, Daiichi Sankyo, and Summit plan to combine Datroway with ivonescimab.

LumaLex Law's Dustin Robinson explains why retatrutide compounding remains illegal regardless of the Seventh Circuit's pending classification ruling.

Artiva Biotherapeutics will present data on AlloNK, an allogeneic, non-genetically modified NK cell therapy given with rituximab, in refractory rheumatoid arthritis, Sjögren disease and systemic sclerosis at ACR Convergence 2026, ahead of a planned phase 3 trial in rheumatoid arthritis.

Novartis has secured an exclusive worldwide license to ABO2203, Abogen's investigational mRNA-encoded CD19xCD3 T-cell engager designed to produce the bispecific inside the body to reset B cells in autoimmune disease. The agreement also includes options on other programs built on Abogen's RNA platform.

The 15-month project could let living cell therapies ship and store at room temperature, cutting cold-chain costs that limit patient access.

Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.

Following an FDA meeting, Wave Life Sciences plans a single 2-year registrational trial of WVE-006, its GalNAc-conjugated RNA editing oligonucleotide for alpha-1 antitrypsin deficiency, with a 1-year interim analysis that could support accelerated approval based on biomarkers.

Patients suffered pyrogenic reactions before Fresenius Kabi recalled 3 contaminated batches at its 430,000-sq-ft Melrose Park, Ill., biologics plant.

Sanofi is paying Regeneron up to $8 billion to co-develop REGN20423 and 3 other long-acting antibodies beyond dupilumab (Dupixent).