Roche won expanded FDA clearance for diagnostic tests linked to Jazz Pharmaceuticals’ Ziihera, expanding companion testing into first-line HER2-positive stomach and gastroesophageal cancers. Roche’s PATHWAY HER2 and VENTANA HER2 Dual ISH DNA Probe Cocktail are now positioned to identify eligible patients across a broader set of metastatic gastroesophageal adenocarcinoma indications. On the regulatory calendar, a separate roundup flags at least nine PDUFA dates on the FDA’s September docket, including orphan indication decisions and an AAV9 gene therapy for Sanfilippo syndrome type A from Ultragenyx.