The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for ...

--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for ...

The FDA on Wednesday approved the industry’s first-ever tablet treatment for spinal muscular atrophy— Roche ’s SMN2 splicing ...

Over the past nine years, patients with spinal muscular atrophy have seen the number of FDA-approved treatment options for ...

Roche (RHHBY) announced that the Food and Drug Administration has approved a New Drug Application for an Evrysdi tablet for people living with ...

The Muscular Dystrophy Association celebrates this new more accessible treatment option for people living with SMA. MDA - New ...

Evrysdi is currently being, or has been, evaluated in numerous global multicentre trials in people with SMA: FIREFISH (NCT02913482) – an open-label, two-part pivotal clinical trial in infants ...

Basel, 12 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for an Evrysdi® (risdiplam ...

Evrysdi is a non-invasive, disease-modifying option that can be swallowed whole or dispersed in water for patients with ...

The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...

Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution – – New tablet formulation may provide greater ...

Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries ; Evrysdi tablet can be stored at room temperature and offers the same demon ...