The FDA cleared Gilead’s hepatitis D therapy Hepcludex (bulevirtide) after a prior rejection tied to manufacturing and distribution issues, giving the first real regulatory foothold for chronic hepatitis D management in the US. The approval also underscores how manufacturing remedies can unlock delayed access for liver disease specialists who have been waiting for years. In breast cancer, the FDA granted a key approval for Daiichi Sankyo and AstraZeneca’s Datroway (datopotamab deruxtecan-dlnk) as a first-line option for unresectable or metastatic triple-negative breast cancer in patients not eligible for PD-1/PD-L1 therapy. The authorization expands the TROP2-directed ADC toolkit and places Datroway into early-line decision pathways. Separately, the EMA backed AstraZeneca’s breast cancer drug despite a negative FDA advisory committee vote, while also issuing conditional approval recommendations for therapies including Boehringer Ingelheim’s Jascayd and Novartis’ Vijoice in defined indications. Together, the EU and US actions reflect continued regulator appetite for ADCs and oncology targeted therapies, even when committees diverge across jurisdictions.