The U.S. Food and Drug Administration has postponed its evaluation of Sanofi’s experimental type 1 diabetes therapy, Tzield, extending the review by more than four weeks due to safety concerns. Regulators flagged a series of serious adverse events during the phase 3 pivotal trial, including multiple seizure episodes and one treatment-related fatality. Sanofi had initially expected a decision by mid-December 2025 under the Trump administration’s Cancer Moonshot Next-Generation Plan for Vaccines (CNPV) fast-track pilot, but the target action date has now slipped into February 2026. Industry analysts say the delay underscores FDA caution over expedited timelines when significant safety signals emerge.

On January 15, 2026, China’s National Medical Products Administration granted approval for two Sanofi-licensed innovative medicines: Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) for familial chylomicronaemia syndrome (FCS). The green light follows positive phase 3 data from the SEQUOIA-HCM study (NCT05186818), which showed a 30% improvement in exercise capacity versus placebo, and the PALISADE trial (NCT05089084), in which Redemplo achieved a median 85% reduction in triglyceride levels from baseline. These nods mark Sanofi’s third and fourth rare disease approvals in Greater China since mid-2025 and reinforce its strategy to target high-unmet-need cardiovascular and metabolic disorders in the region.

Sanofi Chief Executive Paul Hudson warned on January 14, 2026, that U.S. vaccine uptake is likely to experience a modest downturn this year. He attributed the anticipated soft patch to persistent vaccine misinformation campaigns and heightened regulatory scrutiny under the current administration’s public health policies. The company’s U.S. vaccine business, which generated approximately 4.2 billion euros in 2025, could face pressure in the first half of 2026 before market dynamics normalize. Investors will be watching Sanofi’s cost-management initiatives and portfolio rebalancing as the company seeks to offset any revenue drag from the vaccine segment.