The European Medicines Agency’s CHMP issued recommendations this week, including support for ImmunityBio’s Anktiva (nogapendekin alfa inbakicept‑pmin) in BCG‑refractory non‑muscle invasive bladder cancer and a set of other positive opinions that encompass therapies from Hansoh and Cytokinetics. The CHMP opinions align the EMA with recent U.S. and U.K. regulatory movements on selected oncology and cardiology agents. CHMP's recommendation for Anktiva targets patients who have failed intravesical BCG and face cystectomy; the opinion clears a path toward conditional EU marketing authorization. Separately, the committee recommended Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy and supported additional filings from other firms, underscoring continued regulatory throughput as agencies assess benefit‑risk for novel modalities.
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