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BioWorld - Wednesday, February 11, 2026
Home » Topics » Coronavirus, BioWorld

Coronavirus, BioWorld
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FDA rejects EUA for Veru’s sabizabulin, at least for now

March 3, 2023
Shares of Veru Inc. hit a 52-week low March 3 after the U.S. FDA declined to grant an emergency use authorization (EUA) for sabizabulin for use in hospitalized adults with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome. The decision comes as little surprise, given the negative advisory panel vote in November, but the agency’s wording might suggest potential use for the microtubule disruptor in the future.
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Regulatory actions for March 3, 2023

March 3, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Alvotech, Astrazeneca, Checkpoint, Genenta, Intellia, Santhera, Serda, Valneva.
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In the clinic for March 3, 2023

March 3, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amniotics, Biovie, BMS, Brim, Inovio, Janssen, Organogenesis, Poolbeg, Sanofi, Sobi.
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In the clinic for March 2, 2023

March 2, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 23andme, AB, Ambrx, Atom, Cidara, CSL, Deciphera, Emalex, Imcyse, Iveric, Kancera, Karolinska, Lumos, Merck & Co., Moleculin, PDS, Tachyon.
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Regulatory actions for Feb. 28, 2023

Feb. 28, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amo, Asklepios, Biophytis, Glaukos, Orchard, PDS, Priothera, Replimune, Springworks.
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Regulatory actions for Feb. 27, 2023

Feb. 27, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Astrazeneca, Beigene, Chiesi, Daiichi Sankyo, Incyte, Janssen, Merck, Protalix, Regeneron, Ridgeback, Servier, Sobi, Timber.
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In the clinic for Feb. 27, 2023

Feb. 27, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aslan, Astria, Atea, Biocryst, Codexis, Fulcrum, Innocare, Keymed, Merck, Nektar, Nestlé, Orchard, Oscotec, Prilenia, Regenxbio, Tvardi, Werewolf.
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In the clinic for Feb. 24, 2023

Feb. 24, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Molecular, Accutar, Amicus, Astellas, Cantargia, Denali, Forge, Horizon, Janssen, Pharmaessentia, Regenxbio, Sangamo, Skye, Theratechnologies, Viiv.
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Regulatory actions for Feb. 23, 2023

Feb. 23, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Alimera, Cognition, Erydel, Fapon, GSK, Pfizer, PTC, Sage, Seagen, Viiv, Vir.
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In the clinic for Feb. 23, 2023

Feb. 23, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alteogen, Biomx, Corium, Dare, Grid, Immunic, Immunocore, Jaguar, Kinnate, Linkinvax, Merck & Co., Modus, Shionogi.
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