BioRestorative Announces Positive Outcome from Type B Meeting with FDA

BioRestorative completed a Type B meeting with the U.S. Food and Drug Administration (“FDA”) regarding a potential accelerated Biologics License ...
TMCnet

MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day

The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by ...
Cure Today

AVZO-103 Wins FDA Designation for Previously Treated Urothelial Cancer

AVZO-103 targets Nectin4 and TROP2, aiming to deliver anticancer effects precisely to tumor cells, potentially reducing side effects. Fast track designation by the FDA expedites drug development and ...
Cure Today

Alnodesertib Wins FDA Fast Track Status in ATM-Negative Colorectal Cancer

Alnodesertib, combined with irinotecan, targets ATM-negative metastatic colorectal cancer, showing promise in the STELLA study with favorable safety and clinical activity. The FDA's fast track ...