Affinia receives FDA fast track designation for AFTX-201

Affinia Therapeutics has received the US Food and Drug Administration (FDA) fast track designation (FTD) for AFTX-201, a ...

Johnson & Johnson Gets FDA Fast-Track Designation for Nipocalimab in Systemic Lupus Erythematosus

Johnson & Johnson has won U.S. Food and Drug Administration fast-track designation for its investigational nipocalimab drug in adults with systemic lupus erythematosus, a chronic autoimmune disease.

Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM)

AFTX-201 is designed using Affinia's proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids WALTHAM, ...
MPR

Gene Therapy Fast Tracked for BAG3-Associated Dilated Cardiomyopathy

AFTX-201 uses a proprietary capsid to deliver a human BAG3 transgene, aiming to restore cardiac function with lower doses than conventional gene therapies.
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.
Cure Today

FDA Grants Fast Track Status to Muzastotug for Some Colorectal Cancers

The FDA's fast track designation for muzastotug with Keytruda targets microsatellite stable metastatic colorectal cancer without liver metastases, based on promising early clinical evidence.
Nasdaq

Mersana Therapeutics Reports Positive Initial Phase 1 Data for Emi-Le and Receives Additional Fast Track Designation

Mersana Therapeutics announced promising Phase 1 results for Emi-Le in TNBC and received Fast Track designation from the FDA. Mersana Therapeutics, Inc. announced positive initial Phase 1 clinical ...
Healio

FDA fast tracks CAR T-cell therapy for refractory lupus in anticipation of phase 1 trial

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. CB-010, an allogeneic anti-CD19 CAR T-cell therapy, will ...
Nasdaq

With Fast Track Designation in Hand, a Successful Protocol Discussion with FDA, and CROs in Place, Biodexa is on Track to Initiate its Funded Phase 3 Trial in FAP Next Quarter

CARDIFF, UNITED KINGDOM / ACCESS Newswire / March 19, 2025 / Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the ...