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 ...
Nasdaq22d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen for spinal muscular atrophy (SMA). The higher dose regimen of nusinersen comprises a ...
Seeking Alpha15d
Scholar Rock: More Than Just An SMA Biotech With Q2 2025 Obesity Treatment Data
The timeline for a regulatory application submission to the EMA is still slated for Q1 of 2025 ... apitegromab to treat these patients with SMA. It is expected that such additional results ...
Investopedia17d
How to Calculate Moving Average Convergence Divergence (MACD)
An EMA is calculated as follows: Calculate the simple moving average (SMA) for the chosen number of time periods. (The EMA uses an SMA as the previous period's EMA to start its calculations.) ...
pharmaphorum6d
Novartis closes on EU approval for SMA gene therapy Zolgensma
Now, the CHMP has backed conditional approval of Zolgensma for babies and young children with SMA, which could lead to full EMA approval within the next couple of months. Novartis says it will ...
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) ...