FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose ...
Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA
Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New ...
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, ...
Biogen Inc.: FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA CAMBRIDGE, Mass., Jan. 2 ...
The Pharma Letter1d
FDA and EMA accept filings for higher dose of nusinersen in SMA
The US Food and Drug Administration (FDA) has accepted Biogen’s supplemental New Drug Application (sNDA) and the European ...
Managed Healthcare Executive22h
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...
GlobalData on MSN1d
Biogen’s higher dose Spinraza under review by US and EU regulators
Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.
BioSpace1d
Biogen Trims Research Workforce, Higher-Dose SMA Drug Accepted for Regulatory Review
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
FDA and EMA review Biogen's higher dose SMA drug
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...
pharmaphorum1d
US/EU regulators start review of Biogen's high-dose Spinraza
Spinraza remains a big product for Biogen, but has seen its sales go into reverse as competition in SMA treatment has emerged ...
Investing on MSN22h
Ionis stock rises on FDA, EMA nod for SMA drug dose increase
Investing.com -- 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 ...
MM&M22h
Rx Rundown: AbbVie, Purdue Pharma, HHS and more
The Sackler family, owners of Purdue Pharma, reached a $7.4 billion settlement to resolve mass opioid litigation. The Department of Justice filed a civil lawsuit against Walgreens over allegations it ...