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BioWorld - Friday, December 19, 2025
Home » Topics » Briefs » Regulatory actions

Regulatory actions
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Regulatory actions for April 30, 2020

April 30, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Binx Health, Cerus Endovascular, Nines, Refine USA, Rheonix, Synaptive Medical.
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Regulatory actions for April 30, 2020

April 30, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Akarx, Alpha Cognition, Annovis Bio, Banner Life Sciences, Biocardia, Dova, Galectin, Genmab, Glaxosmithkline, Inmed, Junshi, Marker, Medivir, Neon, Pharming, Seelos, Zentalis.
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Regulatory action for April 29, 2020

April 29, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diatherix, Medtronic, Photopharmics, Psychemedics, Senseonics, Vuno.
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Regulatory actions for April 29, 2020

April 29, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amylyx, ANI, Azurrx, Beyondspring, Capricor, Chimerix, Erytech, Merck, Neuraptive, Novartis, Ortho Dermatologics, Remegen.
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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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