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兰修斯获得Lutathera的仿制药竞争对手Bravnesta的批准
2026-09-22 22:39
- The US FDA has granted final approval to Lantheus Holdings' (LNTH) Bravnesta (lutetium Lu 177 dotatate), a bioequivalent to Novartis' (NVS) radiopharmaceutical to Lutathera.
- Bravnesta is used for the treatment of adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
- Bravnesta was approved through the FDA's Abbreviated New Drug Application (ANDA) pathway.
- Earlier in September, Cirium's radioligand therapy Bexlutry (lutetium Lu 177 dotatate) won approval for the same indication. Cirium is in the middle of acquiring Lantheus as part of an $8B deal.
More on Lantheus Holdings
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- Lantheus withdraws, resubmits HSR filing for Curium acquisition
- Novartis' Lutathera now facing generic competition from Curium's Bexlutry
- Seeking Alpha’s Quant Rating on Lantheus Holdings
- Historical earnings data for Lantheus Holdings
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