Browsing Tag
new drug application
3 posts
What Vanda’s December FDA deadlines could mean for motion sickness drug market leadership
Vanda Pharmaceuticals confirms FDA extension of tradipitant clinical hold review to December 5, while motion sickness NDA remains on track for December 30 decision.
Johnson & Johnson seeks FDA approval for SPRAVATO in treatment-resistant depression
Johnson & Johnson (NYSE: JNJ) is seeking U.S. Food and Drug Administration (FDA) approval for SPRAVATO (esketamine) as…
Esketamine nasal spray misses key trial expectations, but Janssen remains optimistic
Janssen Pharmaceutical Companies of Johnson & Johnson encountered a significant setback with their esketamine nasal spray in a…