Zolgensma

CEO of Novartis pledges to speed data integrity disclosures

10 September 2019 | By Rachael Harper (European Pharmaceutical Review)

Novartis reportedly knew of discrepancies in the Zolgensma data it had submitted to the FDA but delayed informing regulators so has announced alterations to its processes.

news

Novartis could face legal action over Zolgensma application

8 August 2019 | By Victoria Rees (European Pharmaceutical Review)

The pharmaceutical company failed to inform the FDA of manipulated data when the gene therapy was under review and could face a legal battle.

news

FDA approves first gene therapy for paediatric spinal muscular atrophy

29 May 2019 | By Victoria Rees (European Pharmaceutical Review)

The FDA has given approval to AveXis for the first treatment of paediatric spinal muscular atrophy (SMA).

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Recommended

Zolgensma

CEO of Novartis pledges to speed data integrity disclosures

Novartis could face legal action over Zolgensma application

FDA approves first gene therapy for paediatric spinal muscular atrophy