Aktis Oncology Receives U.S. FDA Fast Track Designation for AKY-1189, a Nectin-4 Miniprotein Radioconjugate

U.S. FDA Fast Track designation granted to AKY-11891 for the treatment of adult patients with locally advanced or metastatic urothelial cancer ...

Siren Biotechnology Receives FDA Fast Track Designation for SRN-101 for the Treatment of Recurrent High-Grade Glioma

Siren recently announced FDA clearance of its first Investigational New Drug (IND) filing for SRN-101, enabling first-in-human clinical evaluation in patients with recurrent high-grade glioma. SRN-101 ...
CURE

FDA OKs Fast Track to AKY-1189 in Metastatic Urothelial Cancer

FDA granted fast track designation to AKY-1189 for adults with metastatic urothelial cancer after systemic therapy, aiming to speed development of the investigational drug.

Iovance FDA Approval Shifts Lifileucel From Pipeline Bet To Execution Test

Iovance Biotherapeutics (NasdaqGM:IOVA) received FDA approval for lifileucel, marketed as Amtagvi, for metastatic melanoma. The company reported real world data indicating high response rates and a ...

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

MoonLake Immunotherapeutics (NASDAQ:MLTX) ("MoonLake" or the "Company"), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announces that ...
Seeking Alpha

FDA Grants Fast Track Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis with Polyangiitis

PARAMUS, NJ., Sept. 9, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma) a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced today that the U.S Food & Drug Administration (FDA) has ...
Morningstar

FDA Grants Fast Track Designation for AJ201, a First-in-Class Therapy for Kenndy's Disease

TAIPEI, Oct. 22, 2025 /PRNewswire/ -- AnnJi Pharmaceutical Co., Ltd. (AnnJi, TWSE: 7754) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for AJ201, ...
CURE

PLT012 Receives FDA Fast Track Designation for Liver Cancer Treatment

PLT012 received FDA fast track status for liver cancer, with an ongoing trial evaluating safety and early activity of the CD36-targeting immunotherapy.
Nasdaq

FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ Nectin-4 Targeting ADC CRB-701 in Head and Neck Squamous Cell Carcinoma

Dose optimization data from the Phase 1/2 study to be presented next month at ESMO 2025 Second Fast Track designation granted by FDA for CRB-701 CRB-701 (SYS6002) is a next-generation antibody drug ...
Seeking Alpha

Werewolf Therapeutics Receives Fast Track Designation from the U.S. FDA for WTX-124, an Investigational Therapy for the Treatment of Cancer

WATERTOWN, Mass., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (HOWL), pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of ...
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 ...