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BioWorld - Thursday, July 9, 2026
Home » Topics » Briefs » Regulatory actions

Regulatory actions
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Regulatory actions for Oct. 7, 2021

Oct. 7, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Perkinelmer, Venclose.
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Regulatory actions for Oct. 7, 2021

Oct. 7, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Pfizer.
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Regulatory actions for Oct. 6, 2021

Oct. 6, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, GE Healthcare, Syncthink.
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Regulatory actions for Oct. 6, 2021

Oct. 6, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular, Acer, Cocrystal, Intellia, Lexicon, Pfizer, Relief, Rheacell, RDIF, Tenax.
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Regulatory actions for Sept. 28-Oct. 4, 2021

Oct. 5, 2021
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: AB Science, Aim Immunotech, Astellas, Astrazeneca, Basilea, Biontech, Eisai, Everest Medicines, Glenmark, Humanigen, I-Mab, Immunoforge, JW, Kintor, Lipidor, Liscure, Moderna, Pfizer, Takeda, Transcenta, Vifor Fresenius Medical Care Renal Pharma.
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Regulatory actions for Oct. 5, 2021

Oct. 5, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acon Labs, Amber Implants, Iotamotion, Nyxoah.
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Regulatory actions for Oct. 5, 2021

Oct. 5, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Allovir, Arcutis, Astrazeneca, Biontech, Celltrion, Coherus, Cour, Daiichi, Heron, Himalaya, Janssen, Kite, Moderna, Novartis, Pfizer, Relmada, Turning Point, Zosano.
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Regulatory actions for Oct. 4, 2021

Oct. 4, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Labcorp.
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Regulatory actions for Oct. 4, 2021

Oct. 4, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Humanigen, Kite, Omeros, Xbrane.
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Australia map, flag

TGA updates industry on device up-classification requirements

Oct. 1, 2021
By Mark McCarty
Australia’s TGA provided updates regarding up-classification of several device types, including a number of spinal implants, which will henceforth be regulated as high-risk, class III devices, rather than medium-to-high risk devices (class IIb).
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