Zymeworks Receives U.S. FDA Fast Track Designation for ZW191, an FRα-Targeting Antibody-Drug Conjugate

U.S. FDA Fast Track designation granted to ZW191, an antibody-drug conjugate targeting folate receptor-α (FRα), for the treatment of patients ...

Zymeworks Gets FDA Fast-Track Designation for ZW191 in Ovarian Cancer

Zymeworks has won the Food and Drug Administration's fast-track designation for its ZW191 antibody-drug conjugate for patients with advanced or metastatic platinum-resistant ovarian cancer.
Targeted Oncology

FDA Grants Fast Track Designation to FRα-Targeting ADC for Ovarian Cancer

The FDA has granted Fast Track designation to ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-α (FRα), for ...
CURE

FDA Fast Tracks ZW191 for Platinum-Resistant Ovarian Cancer

FDA fast tracked ZW191 for platinum-resistant ovarian cancer, aiming to speed development of a potential new option for patients with limited treatments. The U.S. Food and Drug Administration (FDA) ...
Pulmonology Advisor

FDA Grants Fast Track to siRNA Candidate for HAE Prevention

The FDA has granted Fast Track designation to BW-20805, an investigational small interfering RNA therapy for hereditary angioedema.
Yahoo

Affinia receives FDA fast track designation for AFTX-201

Add Yahoo as a preferred source to see more of our stories on Google. The therapy is being evaluated in the ongoing Phase I/II UPBEAT clinical trial in BAG3 DCM patients. Credit: NMK-Studio / ...
Healio

FDA grants fast track designation to nipocalimab for adults with lupus

The FDA has granted fast track designation to the anti-FcRn agent nipocalimab for the treatment of adults with systemic lupus ...
Renal & Urology News

FDA Provides Fast Track Designation to Nipocalimab for Systemic Lupus Erythematosus

Nipocalimab has been granted U.S. Food and Drug Administration Fast Track designation as a potential treatment for adults with systemic lupus erythematosus (SLE). Fast Track designation is designed to ...
WFMZ-TV

Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE)

Fast Track designation reflects the unmet need in this serious disease and enables the potential for an accelerated FDA review timeline The designation is supported by a Phase 2 study in which ...

Remix Therapeutics Granted FDA Fast Track Designation for REM-422 for the Treatment of Recurrent, Metastatic or Unresectable Adenoid Cystic Carcinoma

Preliminary Phase 1 Study Results Show Strong Anti-Tumor Activity and Favorable Safety Profile for First-in-Class Small ...
Nasdaq

Quoin Pharmaceuticals Announces FDA Grants Fast Track Designation for QRX003 for the Treatment of Netherton Syndrome

— QRX003 lotion (4%) currently being evaluated in two late-stage whole-body clinical trials for treatment of Netherton Syndrome — — Fast Track Designation follows Pediatric Rare Disease and Orphan ...
Healio

FDA grants fast track designation to vectorized antibody to treat ALS

Please provide your email address to receive an email when new articles are posted on . VTx-002 targets proteins that play a significant role in neurodegenerative disease. Enrollment in and ...