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Product regulatory actions for Oct. 18, 2019

Oct. 21, 2019

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

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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...

AI-generated illustration of heart and metabolic impact

Bridgebio, with FDA approval, faces Pfizer in ATTR

BioWorld

With the U.S. FDA approval of Attruby (acoramidis) for transthyretin amyloidosis with cardiomyopathy (ATTR-CM), Bridgebio Pharma Inc. is taking on an industry...

‘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 Oct. 18, 2019