Regulatory events continue to shape biotech and pharmaceutical developments. The FDA approved Boehringer Ingelheim’s targeted pill zongertinib for HER2-mutated lung cancer, advancing options for precision therapies. However, the FDA also issued a safety alert on Boston Scientific’s Watchman device related to embolism risks and expanded limitations on Valneva’s chikungunya vaccine including updated warnings and age restrictions. Internal FDA concerns over staffing and advisory processes were publicly raised, highlighting ongoing operational challenges amid this active period of regulatory oversight.