ABL Bio secures FDA Fast Track for gastric cancer therapy

ABL Bio said Wednesday that the US Food and Drug Administration granted Fast Track designation to Givastomig (ABL111), its ...

NovaBridge Biosciences Receives FDA Fast Track Designation for Givastomig in First-Line HER2-Negative Metastatic Gastric Cancer

Registrational Phase 3 Trial Expected to Begin as Early as Q4 2026Detailed Phase 1b Data Expected to be Presented at a Major ...
Targeted Oncology

FDA Grants Fast Track Designation to VS-7375 for KRAS G12D–Mutated NSCLC

FDA fast-tracks VS-7375, an oral KRAS G12D inhibitor, opening new hope for pretreated advanced NSCLC and fueling pivotal ...

FDA Fast Track opens new path for Imugene's Azer-cel - ICYMI

Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) earlier this week announced that the US Food and Drug Administration (FDA) granted ...

FDA Grants Fast Track Designation to Merakris’ MTX-001, Opening Potential Accelerated Path to Market for Venous Leg Ulcer Therapy

MTX-001 is an investigational biologic therapy being developed to address underlying biological deficiencies associated with impaired wound healing. The therapy is designed to deliver a concentrated ...
Nasdaq

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 ...
Morningstar

4Moving Biotech Granted FDA Fast Track Designation to 4P004, Supporting an Accelerated Development Pathway in Knee Osteoarthritis

FDA Fast Track Designation granted to 4P004 for the treatment of knee osteoarthritis, recognizing the disease as a serious condition with significant unmet medical need Designation supports enhanced ...
Cure Today

FDA Fast Tracks LBL-034 in Relapsed or Refractory Multiple Myeloma

LBL-034, a GPRC5D/CD3 bispecific antibody, was developed using the proprietary LeadsBody platform, featuring a unique two-to-one structure and conditional activation. Fast track designation offers ...