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Roche gets US FDA approval for Evrysdi to treat spinal muscular atrophy expresspharma
August 12, 2020
In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA.
Roche gets FDA nod for Evrysdi to treat spinal muscular atrophy pharmaceutical-business-review
August 11, 2020
Roche has secured approval from the US Food and Drug Administration (FDA) for its Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in adults and children aged two months of age and older.
Genentech secures FDA approval for Evrysdi to treat SMA pharmaceutical-technology
August 11, 2020
Roche unit Genentech has received approval from the US Food and Drug Administration (FDA) for Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in patients aged two months and above.
Biogen to study Spinraza in combination with $2-mn Novartis drug expresspharma
July 22, 2020
The one-a-day oral drug is viewed as a potential a rival to Spinraza, which is administered every four months via spinal infusion.
Novartis firm AveXis gets EC nod for Zolgensma to treat spinal muscular atrophy pharmaceutical-business-review
May 21, 2020
Novartis company AveXis has secured conditional approval from the European Commission (EC) for its Zolgensma (onasemnogene abeparvovec) to treat spinal muscular atrophy (SMA).
Novartis’ AveXis gets EC conditional approval for Zolgensma pharmaceutical-technology
May 20, 2020
Novartis subsidiary AveXis has received conditional approval from the European Commission (EC) for Zolgensma (onasemnogene abeparvovec) to treat spinal muscular atrophy (SMA).
PTC Announces Regulatory Update on Risdiplam for Spinal Muscular Atrophy americanpharmaceuticalreview
April 13, 2020
PTC Therapeutics announced the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of risdiplam to August 24, 2020.
US regulator postpones decision on Roche’s SMA drug risdiplam pharmaceutical-technology
April 09, 2020
The US Food and Drug Administration (FDA) has postponed the decision on Roche’s new drug application (NDA) of risdiplam to treat spinal muscular atrophy (SMA).
Study suggests Zolgensma will generate $2.5bn of global sales by 2025 europeanpharmaceuticalreview
April 01, 2020
According to researchers, Zolgensma, made by Novartis, will lead the global spinal muscular atrophy market and generate billions in sales.
AveXis’ Zolgensma gene therapy yields desired results in SMA trials pharmaceutical-business-review
March 27, 2020
AveXis said that a one-time infusion of Zolgensma (onasemnogene abeparvovec-xioi) delivered rapid, substantial, and clinically meaningful therapeutic benefit ...

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