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FDA Denies Approval of Avasopasem for Radiotherapy-Induced Severe Oral Mucositis

The FDA has issued a complete response letter related to the new drug application for avasopasem manganese. ....

Mel Sorensen , Drug Administration , Galera Therapeutics ,

Galera Reports Second Quarter 2023 Financial Results and Recent Corporate Updates

Company received Complete Response Letter from FDA for avasopasem and intends to request Type A meeting with FDA to discuss potential next steps Cash runway extended into Q2 2024 in connection with.
-Today at 07:02 am- MarketScreener ....

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Galera Lays Off 70% of Staff after FDA Rejection | powderbulksolids.com

The company's shares fell 85% as well. ....

Mel Sorensen , Galera Therapeutics , Fast Track , Breakthrough Therapy ,

FDA Denies Approval of Avasopasem for Radiotherapy-Induced Severe Oral Mucositis

The FDA has issued a Complete Response Letter to Galera Therapeutics regarding the NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis. ....

Mel Sorensen , Drug Administration , Complete Response Letter , Galera Therapeutics , New Drug Application ,

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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