JD Supra

Navigating the CFIUS Fast Track Program

In May 2025, the Treasury Department, as chair of the Committee on Foreign Investment in the United States (CFIUS), announced a new “fast track process to facilitate greater investment in U.S.
EconoTimes

FDA Fast-Track Drug Reviews Delayed Over Safety and Efficacy Concerns

The U.S. Food and Drug Administration has delayed reviews of several drugs selected for the Trump administrations new ...
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 ...
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 ...

Protara Therapeutics Receives Both FDA Breakthrough Therapy and Fast Track Designations for TARA-002 in Pediatric Patients with Lymphatic Malformations

TARA-002 selected for FDA manufacturing development and readiness pilot programNEW YORK, Jan. 05, 2026 (GLOBE NEWSWIRE) -- ...
TMCnet

MapLight Therapeutics Receives Fast Track Designation for ML-007C-MA for Alzheimer's Disease Psychosis

MapLight Therapeutics, Inc. (“MapLight”) (Nasdaq: MPLT) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ML-007C-MA, an investigational novel M 1 ...