Alessa Therapeutics Announces FDA Fast Track Designation for Enolen, A First-Of-Its-Kind Treatment for Localized Prostate Cancer

Alessa Therapeutics ("Alessa"), a clinical-stage biopharmaceutical company advancing novel localized drug delivery technology ...
Healio

FDA fast tracks CTx001 for geographic atrophy

The FDA granted fast track designation for CTx001, an investigational gene therapy candidate for geographic atrophy secondary ...

VectorY Therapeutics Receives FDA Fast Track Designation for VTx-002, a First-in-Class Vectorized Antibody Targeting Underlying Disease Biology in ALS

VectorY Therapeutics, a leader in vectorized antibody therapies for neurodegenerative diseases, announced today that the U.S.
Targeted Oncology

FDA Fast-Tracks PARG Inhibitor for mBRCA Platinum-Resistant Ovarian Cancer

ETX-19477 is a potent, selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG), an enzyme that plays a role in the DNA ...
PharmiWeb

858 Therapeutics Announces FDA Fast Track Designation for PARG Inhibitor ETX-19477 for the Treatment of Patients with BRCA-Mutated, Platinum-Resistant Ovaria…

Fast Track designation granted by U.S. FDA for evaluation of ETX-19477 in patients with BRCA-mutated, platinum-resistant ...
Hosted on MSN

Allarity Therapeutics Wins FDA Fast Track Designation for Ovarian Cancer Drug Candidate Stenoparib

Allarity Therapeutics, Inc. (NASDAQ:ALLR) announced Tuesday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to stenoparib, its investigational treatment for ...

FDA fast-tracks two Merck (MRK) drugs with blockbuster potential

Merck & Co., Inc. (NYSE:MRK) is included among the 14 Best Pharma Dividend Stocks to Buy in 2026. On December 17, the US Food ...

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

Receiving these important FDA designations and invitation to participate in the CDRP program highlights the significant unmet need among pediatric patients with LMs and underscores our belief that ...
Morningstar

FDA Grants Fast Track Designation for CS-1103, a First-in-class Small Molecule to Reverse Acute Intoxication from Methamphetamine

CAMBRIDGE, Mass., Sept. 30, 2025 /PRNewswire/ -- Clear Scientific Inc., a clinical stage biopharmaceutical company focused on the development of first-in-class small molecules to reverse acute ...