The FDA delayed a decision on Exelixis’ colorectal cancer oral tyrosine kinase inhibitor in combination with Roche’s Tecentriq, extending the agency’s timeline following additional review steps. The update adds uncertainty for timing of potential commercialization in metastatic colorectal cancer. Separately, FDA issued a second complete response letter (CRL) to Seikagaku for condoliase (SI-6603), a therapy for radicular leg pain associated with lumbar disc herniation. The agency cited unresolved deficiencies tied to drug substance manufacturing and new cGMP issues at the drug product manufacturing site. Finally, Biohaven disclosed a partial hold affecting its epilepsy program opakalim (BH V-7000), after regulators requested more information about preclinical safety. The halt comes shortly after Biohaven sold off rights to the therapy, affecting trial design needs for a future potential approval pathway.