Browsing Tag
new drug application
5 posts
Could D-PLEX100 turn surgical infection prevention into a breakout story for PolyPid?
PolyPid’s Azurity deal gives D-PLEX100 a U.S. and Canada launch path, with PYPD investors watching FDA acceptance and 2027 approval timing.
Could three FDA submissions turn bezuclastinib into a rare disease and oncology launch engine?
Cogent’s AdvSM NDA gives COGT a third bezuclastinib FDA submission, sharpening its KIT-driven disease franchise and late-2026 launch story.
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…