The FDA issued another complete response letter to Camurus for Oclaiz (CAM-2029) in acromegaly, marking a repeat rejection tied to the subcutaneous extended-release octreotide program. The CRL adds another delay to a product that already received marketing authorization in the EU and the UK. On the approval front, China’s NMPA cleared Suzhou Alphamab’s HER2 bispecific anbenitamab (KN-026) for adults with HER2-positive gastric or gastroesophageal junction adenocarcinoma after trastuzumab-containing regimens, using priority review. The clearance supports a potential new standard in a segment where follow-on HER2 targeting is increasingly competitive. Separately, Guardant Health received FDA approval for Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib) in HER2-mutant advanced NSCLC, reinforcing the growing role of liquid biopsy in accelerating treatment allocation for targeted therapies.