Browsing Tag
FDA Fast Track
18 posts
Glenmark Pharmaceuticals eyes biotech leap as ISB 2001 enters global spotlight
Glenmark Pharmaceuticals’ ISB 2001 gets FDA Fast Track for multiple myeloma. Explore how this could redefine its biotech future and rival global oncology innovators.
May 25, 2025
Amplia Therapeutics secures FDA fast track status for narmafotinib in pancreatic cancer, stock surges
Amplia Therapeutics Limited (ASX: ATX) has announced that its Focal Adhesion Kinase (FAK) inhibitor, narmafotinib, has been granted…
September 20, 2024
Hinova Pharmaceuticals’ HP518 gets FDA fast track designation in triple-negative breast cancer
Hinova Pharmaceuticals Inc. (688302.SH), a trailblazer in the biopharmaceutical industry, has achieved a significant milestone with the U.S.…
July 6, 2024
FDA grants fast track designation to Innovent Biologics’ IBI343 in PDAC
Innovent Biologics, Inc. (HKEX: 01801), a prominent biopharmaceutical firm recognized for its innovative medicines, announced a pivotal advancement…
June 13, 2024
Diamyd Medical advances Diamyd with Phase 3 trial for Type 1 Diabetes
Diamyd Medical has achieved a significant milestone in its pioneering Phase 3 trial, DIAGNODE-3, of Diamyd in Type…
April 14, 2024
Targovax’s ONCOS-102 receives FDA fast track designation for malignant pleural mesothelioma treatment
In a significant development for cancer treatment, Targovax, a Norwegian biotech firm specializing in immune-oncology, has announced that…
February 15, 2021
Cantex Pharmaceuticals’ CX-01 receives FDA fast track designation in acute myeloid leukemia
Cantex Pharmaceuticals, a Florida-based biotechnology company, has achieved a significant milestone by securing Fast Track designation from the…
August 27, 2018
Aravive Biologics’ AVB-S6-500 receives FDA fast track designation for ovarian cancer
Aravive Biologics, a biopharmaceutical company, has received Fast Track designation from the U.S. Food and Drug Administration (FDA)…
August 20, 2018