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BioWorld - Tuesday, April 7, 2026
Home » Topics » Briefs » Regulatory actions

Regulatory actions
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Regulatory actions for July 15, 2021

July 15, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkeus, Antengene, Immunitybio, Kintor, Qualigen, Ryvu, Sesen.
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Regulatory actions for July 14, 2021

July 14, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coaptech, Tidal Medical.
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Regulatory actions for July 14, 2021

July 14, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Arca, Artax, AVM, Evgen, Innovent, Moleculin, Oryzon, Targovax, Valo.
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Regulatory actions for July 6-12, 2021

July 13, 2021
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Beigene, Hangzhou Chance, Humanigen, Immutep, Innovent, Janssen-Cilag International, Moderna, Opthea, Recipharm, Replicel Life Sciences, Sciclone, Y-Mabs, Zydus Cadila.
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Regulatory actions for July 13, 2021

July 13, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: East End Medical, Stryker, Xenios.
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Regulatory actions for July 13, 2021

July 13, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Antengene, Bayer, Chemocentryx, Coya, Diurnal, Enochian, Gensight, Inotrem, Iveric, Janssen, Kintor, Prilenia, Provention, Seagen, Sigilon, Sirnaomics, Soleno, Tetra, Tevogen, Valneva.
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Pivot breath sensor and app on phone

Carrot tweaks labeling for smoking cessation breathalyzer

July 12, 2021
By Ana Mulero
Looking to increase adoption among more tobacco users, Carrot Inc. expanded the indications for use of its smoking cessation breathalyzer with a new FDA 510(k) clearance to include the claims related to a recent study in the labeling and promotion of the sensor. The clinical trial demonstrated the Bluetooth-enabled sensor’s ability to increase a person’s motivation to quit.
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Regulatory actions for July 12, 2021

July 12, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carrot, Quidel, Ortho Clinical Diagnostics, Uvision360.
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Regulatory actions for July 12, 2021

July 12, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Bluebird, Humanigen, Innovent, Lysogene.
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Regulatory actions for July 9, 2021

July 9, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Flowvision, Qiagen.
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