A Cancer Driven by Ultra-Rare Mutation Gets Its First FDA-Approved Therapy

Frank Vinluan / medcitynews - Partner Therapeutics’ Bizengri is now FDA approved for treating advanced cases of cholangiocarcinoma driven by NRG1 gene fusions. Partner acquired U.S. rights to this bispecific antibody from Merus in 2024. The post A Cancer Driven by Ultra-Rare Mutation …

AI Summary: The FDA approved zenocutuzumab‑zbco for NRG1‑fusion–positive cholangiocarcinoma, delivering the first cleared therapy for cancers driven by this ultra‑rare genomic alteration. Trial data showed meaningful responses in heavily pretreated patients, prompting regulators to greenlight a precision option that offers targeted benefit where none existed — a small‑population win for genomic oncology.

With Commissioner Under Pressure, F.D.A. Opens Door to Flavored Vapes

Christina Jewett / nytimes - Though illicit e-cigarettes have flooded in from China, the new policy could allow major tobacco companies to sell from prime shelf space at thousands of stores.

AI Summary: Facing mounting pressure, the FDA has signaled authorization of fruit‑flavored vaping products for adults, a regulatory shift framed as adult access and harm reduction. Public‑health experts warn the move risks increasing youth appeal and reignites debate over flavors, enforcement, and whether potential population‑level tradeoffs were adequately considered.