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BioWorld - Sunday, January 11, 2026
Home » Topics » Briefs » Regulatory actions

Regulatory actions
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Regulatory actions for April 21-27, 2020

April 28, 2020
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Algernon, Arch Biopartners, Beigene, Biontech, Biosig Technologies, Caladrius, Carsgen, Chugai, Clarity, Cstone, Diffusion, Eli Lilly, Halozyme, Hope Biosciences, Immuneoncia, Innovent Biologics, Janssen, Mateon, Oryzon Genomics, Pfizer, Rafael, Revive, Samsung Biologics, Shanghai Green Valley, Takeda, Viralclear, Vitro Diagnostics.
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Regulatory action for April 28, 2020

April 28, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chronolife, Edwards Lifesciences, Exthera, Icecure, Life Spine, Lungpacer Medical, Medipines.
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Regulatory actions for April 28, 2020

April 28, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptimmune, Bioeclipse, Moderna, Moleculin, Pharmamar, Retrotope, Roche, Sanofi, Shionogi, Zambon.
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Regulatory action for April 27, 2020

April 27, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Livanova, Personal Genome Diagnostics.
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Regulatory actions for April 27, 2020

April 27, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Carmell, Carsgen, Cytodyn, Diffusion, Eiger, Green Valley, Halozyme, Janssen, Mateon, Neurocrine, Polyneuron, Takeda.
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Alung-hemolung-system.png

FDA OKs emergency use of Alung’s Hemolung for COVID-19 patients

April 24, 2020
By Meg Bryant
Pittsburgh-based Alung Technologies Inc. has received emergency use authorization from the U.S. FDA for its Hemolung Respiratory Assist System (RAS) to treat lung failure caused by COVID-19. The technology could help to ease demand for ventilators, which have been in short supply in coronavirus hot spots, and provide an alternative for patients who can’t tolerate mechanical ventilation.
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Regulatory action for April 24, 2020

April 24, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Vela Diagnostics.
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Regulatory actions for April 24, 2020

April 24, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Biosig, Innovent, Janssen, Lilly, Oryzon, Sanofi, Viralclear.
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Regulatory actions for April 23, 2020

April 24, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amidebio, Caladrius, CNS Pharma, Cstone, Immuneoncia, Immunomedics, Merck and Co., Rafael, Revive, Samsung Biologics, Vitalis.
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Regulatory action for April 23, 2020

April 23, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Baxter, Biocomposites, Cagent Vascular, Mevion.
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