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 ...

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

Enolen is currently being studied in a Phase 1 trial evaluating its safety, tolerability and preliminary efficacy for localized sustained delivery of enzalutamide into the prostate. Alessa expects to ...
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 ...

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.

INTENT Biologics Receives FDA Fast Track Designation for PEP Biologic™

INTENT Biologics, a clinical-stage biotechnology company developing first-in-class exosome-based biologic therapies for serious conditions with significant unmet medical need, announced today that the ...
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 ...

AskBio Announces FDA Acceptance of Investigational New Drug (IND) Application for AB-1009 Gene Therapy for Treatment of Late-Onset Pompe Disease (LOPD)

AB-1009 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. For more information, ...
Medindia

Complement Therapeutics Announces FDA Fast Track Designation for CTx001 for the Treatment of Geographic Atrophy Secondary to AMD

Complement Therapeutics GmbH (CTx), a clinical-stage biotechnology company developing next-generation therapeutics for complement-mediated diseases, today announced that the U.S. Food and Drug ...

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 ...
Washington Examiner

FDA opens fast-track review process for national health priorities

The Food and Drug Administration announced the launch of a new program to fast-track agency approvals for drug manufacturers working on products that could cure chronic disease, prepare for a pandemic ...
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 ...