The $185B Cancer Surge: Why the FDA's Fast-Track Pivot is Scaling a New Immunotherapy Era

Oncolytics also recently expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, positioning the company for ...
ALS News Today

ALS gene therapy targeting TDP-43 protein put on FDA fast track

The FDA granted fast track status to VectorY’s VTx-002, an antibody gene therapy targeting TDP-43 protein aggregates in ALS.
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

Corbus higher as FDA issues another fast track tag for lead asset

Corbus Pharmaceuticals (NASDAQ:CRBP) traded ~10% higher on Tuesday after the U.S. Food and Drug Administration (FDA) granted another Fast Track designation for the cancer drug developer’s lead asset, ...
Hosted on MSN

Adagene, Palvella gain after FDA fast track designations

Adagene (ADAG) and Palvella Therapeutics (PVLA) traded higher in the premarket on Tuesday after the Food and Drug Administration issued its Fast Track Designations to the companies’ experimental drugs ...
Business Wire

Cartography Receives FDA Investigational New Drug (IND) Approval and Fast Track Designation for Lead Program CBI-1214 for Colorectal Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cartography Biosciences, Inc., a biotechnology company advancing a differentiated pipeline of antibody-based cancer therapies, today announced that the ...
JD Supra

Rare Disease Focus: FDA’s Trio of Cell and Gene Therapy Draft Guidances Highlight Expedited Programs, Innovative Trial Designs, and Postapproval Evidence Generation

FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene ...