Targeted Oncology

FDA Grants Fast Track Designation to Suplexa for MSI-H Colorectal Cancer

FDA fast track status was supported by two monotherapy responses in MSI-H colorectal cancer, including one complete response ...

INmune Bio Receives FDA Fast Track Designation for XPro1595 in Early Alzheimer's Disease

INmune Bio Inc. (NASDAQ: INMB), a late-stage biotechnology company focused on inflammation and immunology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...

Coya Therapeutics secures FDA fast track status for COYA 302

Learn more Coya Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for COYA 302, ...
ALS News Today

FDA puts injection therapy COYA 302 on fast track for treating ALS

COYA 302, an injection therapy in development for the treatment of ALS, has been awarded fast track status by the U.S. Food and Drug Administration. The therapy aims to slow ALS progression by ...
Healio

FDA grants fast track designation to intra-articular GLP-1 analog for knee osteoarthritis

The FDA has granted fast track designation to 4P004, a GLP-1 agonist analog, for the treatment of knee osteoarthritis, ...
Targeted Oncology

FDA Grants Fast Track Designation to RPTR-1.201 for Advanced TNBC

FDA fast track designation enables increased regulatory interaction and potential rolling BLA review for RPTR-1.201 in ...

Zai Lab wins FDA fast track status for cancer drug Zocilurtatug Pelitecan

Zai Lab (ZLAB) said the U.S. FDA granted fast track designation to its experimental cancer drug zocilurtatug pelitecan for treating extrapulmonary neuroendocrine carcinomas after standard first-line ...

Sironax’s SARM1 Inhibitor SIR2501 Granted FDA Fast Track Designation in Chemotherapy-induced Peripheral Neuropathy (CIPN)

CIPN is a common nerve-damaging side effect of chemotherapy with no FDA-approved treatment optionsFast Track designation ...

Scancell receives FDA Fast Track Designation for iSCIB1+ in advanced melanoma and provides data update from its SCOPE Phase 2 study

Potent and durable efficacy with iSCIB1+ of 77% progression free survival (PFS) at 20 months, in combination with ipilimumab and nivolumab, ...
PharmiWeb

Coya Therapeutics Has Been Granted U.S. FDA Fast Track Designation for COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with ...