The FDA extended Exelixis’ review timeline for its metastatic colorectal cancer drug candidate after the company submitted new safety and efficacy data, according to the company’s filings. Separately, the agency delayed an approval decision for Exelixis’ colorectal cancer tyrosine kinase inhibitor in combination with Roche’s Tecentriq. On the neurology side, FDA placed a partial hold on Biohaven’s epilepsy drug BHV-7000 days after the asset was tied to a pending $350 million deal. The hold followed regulator requests for additional preclinical safety information. Taken together, the actions highlight how late-stage data and preclinical package completeness continue to drive timetable risk across oncology and CNS drug development.