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BioPharma Dive·2h ago·1 min read
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FDA approves first generic radioligand therapy for neuroendocrine tumors as Sionna announces major layoffs

Sep 15, 2026·read at BioPharma Dive ↗ApprovalNeutral

The U.S. Food and Drug Administration has cleared Bexlutry, the first generic version of Novartis’ Lutathera, marking the debut of a radioligand therapy that can be used for SSTR‑positive neuroendocrine cancers.

The clearance follows Curium’s victory in a patent dispute with Novartis, opening the market for a lower‑cost option in treating foregut, midgut and hindgut tumors.

At the same time, Sionna Therapeutics said it will lay off roughly half of its workforce and revise its clinical development strategy after a key cystic fibrosis trial failed to meet expectations.

The roundup also noted Novo Nordisk’s rebranding and early promise from a novel RNAi candidate, but the FDA approval and Sionna’s layoffs dominate the headlines.

source

This writeup was produced by pharmadog from original reporting by BioPharma Dive.

Original headline: “FDA clears first generic radioligand drug; Sionna turns to layoffs”

read at BioPharma Dive ↗
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companies & drugs in this story

companies
NOVO8CURIUM4NOVARTIS4Novo Nordisk Inc4ELI LILLY COJOHNSON & JOHNSONLILLYSionna Therapeutics, Inc.
drugs
lutetium Lu 177 dotatate5CRB-9132Obesity2
topics
Approval3Major Depression3Radioligand Therapy3siRNA3Cystic Fibrosis2Hematology2Hyperlipidemia2Obesity2CardiologyGLP-1 receptorOncology

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