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BioWorld - Thursday, January 8, 2026
Home » Topics » Regulatory

Regulatory
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U.S. Capitol building

Domestic Rx, device supply chain a tall order

Aug. 10, 2020
By Mari Serebrov
“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.
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Regulatory front for Aug. 10, 2020

Aug. 10, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Covidien, Medtronic, MITA.
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Regulatory actions for Aug. 10, 2020

Aug. 10, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Helix, Nanotronics Health.
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Regulatory front for Aug. 10, 2020

Aug. 10, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Aurinia, Glaxosmithkline.
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Regulatory actions for Aug. 10, 2020

Aug. 10, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Appili, Aquestive, Chi-Med, Diurnal, Gilead, Mallinckrodt, Ocugen, Pluristem, Reata, Seelos, Trevena, Vaxart.
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FDA approves Olinvyk for acute pain

Aug. 10, 2020

FDA approves Evrysdi for spinal muscular atrophy

Aug. 10, 2020

PTC’s risdiplam gets FDA nod as first at-home SMA therapy

Aug. 7, 2020
By Jennifer Boggs
More than two weeks ahead of its expected PDUFA date, PTC Therapeutics Inc.’s spinal muscular atrophy (SM) drug, risdiplam, gained FDA approval, making it the first at-home, oral treatment intended for use in adults and children 2 months and older.
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Digital heart illustration

NMPA approves the first AI ECG diagnostic machine

Aug. 7, 2020
By Bryan Wong
HONG KONG – A Chinese med-tech company plans to take to market what it claims is the first electrocardiography (ECG) diagnostic machine powered by AI, but as it moves to markets beyond China, it could face significant competition.
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Regulatory front for Aug. 7, 2020

Aug. 7, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MITA.
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