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Product regulatory actions for October 29, 2019

Oct. 30, 2019

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations.

BioWorld MedTech Briefs Regulatory actions

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J&J’s Ottava robotic system approved for US pivotal trial

BioWorld MedTech

Johnson & Johnson received U.S. FDA investigational device exemption to begin the pivotal clinical trial for the Ottava robotic surgical system. If the trial goes...

Illustration of man holding magnifying glass to human body model showing muscle anatomy

In muscular dystrophies, gene therapies race the clock

BioWorld

Since the isolation of the gene that causes Duchenne muscular dystrophy (DMD), scientists have progressed in understanding the mechanisms that lead to muscular...

‘Evo’ AI can design complete genomes

BioWorld Science

The development of new machine learning tools like Alphafold and Rfdiffusion has allowed scientists to predict the structure of proteins and design them for drug...

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Product regulatory actions for October 29, 2019