An FDA advisory committee may have ruled in elamipretide’s favor back in October, but it looks like Stealth BioTherapeutics ...

The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...

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. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...

Johnson & Johnson JNJ announced that the FDA has approved its supplemental new drug application (sNDA), seeking approval for ...

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 LAWSUIT: A class action securities lawsuit was filed against Applied Therapeutics, Inc. that seeks to recover losses of shareholders who were adversely affected by alleged securities fraud between ...

With one year left to comply with the FDA's Food Traceability Rule, companies have made progress but still face challenges.

The study identified gene expression changes which were detected beginning three months after intranasal dosing of foralumab in our ongoing ISPPEA (or expanded access program). Key findings include ...

About half of U.S. adults have high blood pressure, a major risk for heart attacks, strokes, kidney failure, even dementia.

Zai Lab Limited (ZLAB) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation or ODD to ZL-1310, a ...