Browsing Tag
Fast Track designation
5 posts
Can oral NMDA blockers like Ketamir-2 disrupt current off-label CIPN treatments?
Find out how MIRA Pharmaceuticals’ Ketamir-2 aims to disrupt CIPN care with oral NMDA therapy as the company targets Fast Track and prepares for Phase 2a trials.
Incannex Healthcare secures FDA Fast Track designation for IHL-42X in obstructive sleep apnea treatment market
Find out how Incannex Healthcare’s IHL-42X earned FDA Fast Track status and why it could transform oral treatment for obstructive sleep apnea.
Clarity Pharmaceuticals bags FDA fast track designation for prostate cancer candidate 67Cu-SAR-bisPSMA
Clarity Pharmaceuticals has achieved a major regulatory milestone with the United States Food and Drug Administration (FDA) granting…
Telix Pharmaceuticals submits NDA for Pixclara to advance brain cancer imaging
Telix Pharmaceuticals Limited (ASX: TLX) has taken a significant step in the realm of neuro-oncology by submitting a…
Phanes Therapeutics’ PT217 receives FDA orphan drug designation for neuroendocrine carcinoma
Phanes Therapeutics, Inc., a clinical-stage biotechnology company dedicated to advancing oncology treatments, has achieved a significant milestone with…