PharmiWeb

4Moving Biotech Granted FDA Fast Track Designation to 4P004, Supporting an Accelerated Development Pathway in Knee Osteoarthritis

FDA Fast Track Designation granted to 4P004 for the treatment of knee osteoarthritis, recognizing the disease as a serious ...
Targeted Oncology

FDA Grants Fast Track Designation to BBO-11818 in KRAS-Mutant PDAC

FDA fast track designation supports expedited development and regulatory interaction for BBO-11818 in advanced KRAS-mutant ...

Thryv Therapeutics Commences Patient Dosing in Wave II Clinical Study for Long QT Syndrome and Receives FDA Fast Track Designation for THRV-1268

Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing novel serum glucocorticoid inducible kinase 1 (SGK1 ...
Targeted Oncology

FDA Grants Fast Track Designation to ADC for Platinum-Resistant Ovarian Cancer

Fast Track status enables closer FDA engagement to potentially accelerate development of a CDH6-directed ADC in ...

BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma

BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in subjects with locally advanced unresectable or metastatic KRAS-mutant ...

Following Oral Presentation of Phase I Data at AACR 2026, Debiopharm Announces FDA Fast Track Designation for Lunresertib in Combination With Zedoresertib for Genomic-Defined ...

Debiopharm ( a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow's standard of care to cure cancer and infectious diseases, today announced that the U.S. Food and ...

Polaryx Therapeutics Gets FDA Fast Track Designations for Its Lead Drug Candidate

Polaryx Therapeutics has now been granted fast track designation by the Food and Drug Administration for all four indications it is testing with its lead drug candidate. The last FDA decision adds ...

Medera Receives FDA Fast Track Designation for Gene Therapy Targeting Duchenne Muscular Dystrophy-Associated Cardiomyopathy

Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company developing next-generation cardiovascular therapeutics, and its clinical development division Sardocor, today announced that the U.S.
Yahoo Finance

Polaryx Therapeutics Receives U.S. FDA Fast Track Designations for All Four Indications to be Evaluated in the SOTERIA Basket Trial

PARAMUS, N.J., April 21, 2026 (GLOBE NEWSWIRE)-- Polaryx Therapeutics, Inc. (Nasdaq: PLYX), a clinical-stage biotechnology company developing disease-modifying therapies for rare pediatric LSDs, today ...
WFMZ-TV

Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE)

"Nipocalimab earning its fifth FDA Fast Track designation, now in systemic lupus erythematosus, reflects the importance of accelerating the delivery of an immunoselective therapy that could fill an ...
Yahoo

Affinia receives FDA fast track designation for AFTX-201

Add Yahoo as a preferred source to see more of our stories on Google. The therapy is being evaluated in the ongoing Phase I/II UPBEAT clinical trial in BAG3 DCM patients. Credit: NMK-Studio / ...