TriCelX Files IND with FDA & Concurrently Requests RMAT Designation for XytriX™ in the Treatment of Knee Osteoarthritis

IND Filing and Concurrent RMAT Request Position XytriX™ as a Potential Breakthrough Biotherapeutic for More Than 500 ...

Quantum BioPharma Submits Investigational New Drug (IND) Application to United States Food and Drug Administration (FDA) for Lucid-MS Phase Two Clinical Trial in Multiple Sclerosis

The IND submission includes data from nonclinical pharmacology and toxicology studies, along with manufacturing and quality information, to support initiation of the planned Phase 2 clinical trial.

Telomir Pharmaceuticals Submits IND to FDA for Telomir-1 (Telomir-Zn) in Advanced and Metastatic Triple-Negative Breast Cancer

First-in-class metal-modulating epigenetic therapy targeting iron-dependent pathways with preclinical efficacy and a ...
Healio

FDA accepts IND for synthetic psilocybin therapeutic to treat PTSD

Please provide your email address to receive an email when new articles are posted on . The acceptance paves the way for a pending phase 2b/3 clinical trial of COMP360 in PTSD. The manufacturer plans ...

Ultragenyx Pharmaceutical Announces FDA Acceptance of UX016 IND

RARE's IND for UX016, a novel sialic acid prodrug targeting GNEM, a rare muscle disease, gets accepted by the FDA. The ...

EndoCyclic Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for ENDO-205, a First-in-Class Non-Hormonal Precision Peptide Therapeutic for ...

Unlike existing therapies that primarily suppress symptoms through hormonal modulation, ENDO-205 is the first candidate in development designed to eliminate endometriosis lesions and address ...

Ultragenyx Announces FDA Clearance of Investigational New Drug (IND) Application for UX016, a Sialic Acid Prodrug for the Treatment of GNE Myopathy

Program to be externally funded by a venture philanthropy agreement through clinical proof-of-concept, including the Phase 1/2 study planned to begin in the second half of 2026NOVATO, Calif., March 30 ...

Quality Longevity Company Enlivex Receives Investigational New Drug (IND) Clearance from the FDA for Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee ...

Enlivex’s first regulatory approval for a late-stage global Phase 2b study in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis ...
Healio

FDA clears investigational new drug application for NOV05

Please provide your email address to receive an email when new articles are posted on . NOV05 will be evaluated in patients with noninfectious anterior uveitis. Novaliq plans to initiate a phase 2 ...