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FDA reviews a proposed Keytruda biosimilar, Roche expands its obesity pipeline with an RNAi deal, and guselkumab shows promise for fistula remission in Crohn disease.

Dr. Paz Vellanki discusses Bayesian methods, challenges in developing rare disease endpoints, and why sponsors should engage FDA early in clinical development.

Johnson & Johnson's guselkumab achieved up to 29% fistula remission in hard-to-treat Crohn disease subgroups, including prior biologic failures.

Rona's ALK7 RNAi candidate, licensed to Roche for up to $1.06 billion in milestones, aims to cut visceral fat while sparing lean mass.

FDA has accepted for review the biologics license application for FYB206, a proposed pembrolizumab biosimilar developed without a comparative phase 3 efficacy trial. A decision could come in the third quarter of 2027.

In an eight-week obese non-human primate study, lean mass made up 6% of the weight lost with iBio’s Activin E antibody IBIO-610 plus semaglutide, compared with 22% with semaglutide alone. iBio plans to begin first-in-human studies in the first half of 2027.

Clinical results reveal new opportunities and setbacks in rare disease and cancer care, shaping treatment strategies and future regulatory decisions.

Phase 3 interim data for RYZ101, the lead asset from Bristol Myers Squibb’s $4.1 billion RayzeBio deal, meet the primary endpoint.

Efzimfotase alfa missed significance on the six-minute walk test in adolescents and adults, while the FDA review of the therapy proceeds toward 2027.

MT027, T-MAXIMUM's B7-H3 CAR-T therapy, earns a second FDA-cleared phase 2 trial, now testing lung and breast cancer brain metastases.

New clinical data highlight improved disease control, reduced eye bulging, and weight-loss benefits, potentially broadening options for patients with unmet needs.

Antisense oligonucleotides are reshaping drug design, from RNase H gapmers to inhaled delivery; this FAQ explains how they work and why trials still fail.

Bristol Myers Squibb's Nathan Pennell explains how the MRD endpoint supports accelerated approval in multiple myeloma without changing how clinicians monitor patients.