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BioWorld - Saturday, April 11, 2026
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Regulatory actions for Oct. 17, 2024

Oct. 17, 2024
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Astria, GSK, ipsen, Novavax, Theriva, Tonix, Urogen.
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FDA pauses Novavax’s flu and COVID-19 combo vaccines

Oct. 16, 2024
By Jennifer Boggs
Shares of Novavax Inc. (NASDAQ:NVAX) dropped nearly 20% Oct. 16 to close at $10.15 after the company reported a serious adverse event had prompted a U.S. FDA clinical hold for its COVID-19-influenza combination and standalone flu vaccine candidates.
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In the clinic for Oct. 10, 2024

Oct. 10, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aurigene, Clearside, Dyne, Entrada, Innocare, Insmed, Panavance, Tevogen, Vanqua, Viatris, Viking.
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In the clinic for Oct. 4, 2024

Oct. 4, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Ennodc, Expert Systems, Irlab, Theriva, Trawsfynydd.
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Other news to note for Oct. 3, 2024

Oct. 3, 2024
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biotheus, Eliem, Emergex, Frazier, Gilead, Immunoprecise, Intelgenx, J&J, Novaliq, Verrica.
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Regulatory actions for Oct. 2, 2024

Oct. 2, 2024
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bpgbio, Clinuvel, Daiichi, Formycon, Fresenius, Invivyd, Ionis, J&J, Oryzon, Papillon, PTC, Sagimet, Thryv.
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In the clinic for Oct. 1, 2024

Oct. 1, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alnylam, Anagram, Angitia, Ascendis, BMS, Bridgebio, Cereno, Cour, CSL, Enliven, Estrella, Janssen, Kezar, Madrigal, Neurobo, Ocuphire, Pop, Poseida, Rivus, Windtree.
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Regulatory actions for Sept. 23, 2024

Sep. 23, 2024
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amplia, Apellis, Biocon, Biotech, Ipsen, Janssen, Johnson & Johnson, Merck, Novo Nordisk, Pfizer, Samsung Bioepis, Sanofi.
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Regulatory actions for Sept. 19, 2024

Sep. 19, 2024
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Applied, Astrazeneca, Azitra, Briacell, Glycomine, Imcheck, Merck, Moderna, Nicox, Novartis, Valneva.
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In the clinic for Sept. 16, 2024

Sep. 16, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atea, Curevac, Hotspot Therapeutics, Immuneering, Moberg, Neurocrine, Vico, Zambon.
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