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Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese

Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese
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Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese

The Company remains committed to its goal of bringing avasopasem to patients and intends to meet with FDA as soon as possible to discuss potential next steps Galera will take actions to extend its. ....

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Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese

Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese
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Galera Presents Additional Chronic Kidney Disease Data from ROMAN Trial at 2023 ASCO Annual Meeting

As previously reported, avasopasem reduced cisplatin-related chronic kidney disease by 50% compared to placebo at one-year follow-up Additional data demonstrated improved preservation of kidney. | June 5, 2023 ....

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