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Monday, 01 June 2026
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TGA tick highlights genetic testing

Posted 1 June 2026 PM

Biogen has welcomed the TGA granting provisional approval for its targeted neurological disorder drug Qalsody, saying it highlights the importance of genetic testing to understand the genetic causes of degenerative diseases.

The TGA granted provisional approval for Qalsody, the first targeted disease-modifying treatment for people in Australia with amyotrophic lateral sclerosis (ALS) who have a superoxide dimutase 1 (SOD1) gene pathogenic variant, one of the mutations that cause ALS. The approval to treat ALS, also known as motor neuron disease (MND), came at the same time as a recommendation from the PBAC for the indication. 

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