Single-country clinical trial results: Are they applicable to other populations?

FDA releases 10 guiding principles for AI use in drug development

FDA, in collaboration with the European Medicines Agency, has published 10 principles to help guide pharmaceutical companies using artificial intelligence to develop drug, biological, and medical devices.

January 16, 2026

By Sara Willa Ernst

Cancer Policy

FDA to increase regulatory flexibility for development of cell and gene therapies

FDA has released additional information on its “flexible approach” to regulating chemistry, manufacturing and control, or CMC, requirements for cell and gene therapies.

January 16, 2026

By Jacquelyn Cobb

Clinical Roundup

Rybrevant leads to anti-tumor activity and durable responses in CRC, phase I/II follow-up results show

Longer follow-up results from the investigational phase Ib/II OrigAMI-1 study evaluating amivantamab-vmjw, a bispecific antibody targeting epidermal growth factor receptor and MET, in combination with FOLFOX or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic colorectal cancer were presented during a poster session at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

January 16, 2026

Clinical Roundup

Bepirovirsen demonstrates positive results in chronic hepatitis B, phase III trials show

Positive results were announced from its two pivotal phase III trials, B-Well 1 and B-Well 2, evaluating bepirovirsen, an investigational antisense oligonucleotide for the treatment of chronic hepatitis B in over 1,800 patients from 29 countries.

January 16, 2026

Clinical Roundup

Mutation predicts chemoresistance and better responses to immunotherapy in advanced bladder cancer, MD Anderson study finds

Researchers at The University of Texas MD Anderson Cancer Center have determined that mutations in the KDM6A gene—common in advanced bladder cancer—may serve as a predictive biomarker to determine which patients are less likely to benefit from standard chemotherapy but may respond better to immunotherapy.

January 16, 2026

Drugs & Targets

FDA accepts NDA for pimicotinib for treatment of tenosynovial giant cell tumor

FDA accepted the new drug application for pimicotinib (ABSK021) as a systemic treatment for patients with tenosynovial giant cell tumor.

January 16, 2026

Single-country clinical trial results: Are they applicable to other populations?

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FDA releases 10 guiding principles for AI use in drug development

FDA to increase regulatory flexibility for development of cell and gene therapies

Rybrevant leads to anti-tumor activity and durable responses in CRC, phase I/II follow-up results show

Bepirovirsen demonstrates positive results in chronic hepatitis B, phase III trials show

Mutation predicts chemoresistance and better responses to immunotherapy in advanced bladder cancer, MD Anderson study finds

FDA accepts NDA for pimicotinib for treatment of tenosynovial giant cell tumor

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