Nasdaq15d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
The higher dose regimen of nusinersen comprises a more ... As a foundation of care in SMA, more than 14,000 individuals have been treated with SPINRAZA worldwide.1 The currently approved 12 ...
Ionis stock rises on FDA, EMA nod for SMA drug dose increase
Shares of Ionis Pharmaceuticals (NASDAQ:IONS) climbed 7% today after the company announced that regulatory agencies in the United States and Europe have accepted applications for a higher dose regimen ...
Benzinga.com23d
Scholar Rock Sets Sights on $2 Billion Apitegromab Revenue Amid Spinal Muscular Atrophy Market Growth
Detailed results from the phase 3 SAPPHIRE trial, which involves patients with non-ambulatory type 2/3 SMA treated with Spinraza (nusinersen) or Evrysdi (risdiplam), are expected to be presented ...
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
Yahoo Finance15d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
has validated the application for a higher dose regimen of nusinersen for spinal muscular atrophy (SMA). The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg ...
Stockhouse15d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
2 SPINRAZA has shown sustained efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to 10 years,3,4 combined with unsurpassed real-world ...