FDA accelerated approval

2 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Prokidney Corp.

ProKidney Secures $270M Cash Position, Eyes Mid-2027 Approval for Kidney Disease Treatment

ProKidney reports $270M cash reserves extending operations to mid-2027, achieves FDA alignment on accelerated approval pathway for rilparencel with Phase 3 enrollment progressing ahead of schedule.
PROKclinical trialchronic kidney disease
GlobeNewswire Inc.GlobeNewswire Inc.··Levi & Korsinsky, Llp

Inovio Hit With Securities Lawsuit Over FDA Approval Claims

Levi & Korsinsky files class action against Inovio Pharmaceuticals alleging management misrepresented FDA accelerated approval eligibility for lead candidate, causing stock decline.
INOsecurities class actionBiologics License Application