SHINKEI THERAPEUTICS GETS FDA CLEARANCE FOR MR-101 TRIAL & COMPLETES PHASE 2 FOR MR-301 IN TRAUMATIC BRAIN INJURY

SHINKEI THERAPEUTICS RECEIVES FDA CLEARANCE TO PROCEED WITH PHASE 1 CLINICAL TRIAL FOR MR-101 AND COMPLETES PHASE 2 ...
Ophthalmology Times

FDA clears phase I/II trial of SVT-001 cell therapy for familial drusen–associated vision loss

FDA authorization under an IND permits first-in-human phase I/II testing of SVT-001 in familial drusen, focusing on safety ...

FDA releases hold on second of Intellia’s ATTR-CM gene therapy trials

Intellia is now able to continue both Phase III trials of nex-z. Credit: Piotr Swat / Shutterstock.com (Piotr Swat / Shutterstock.com) The US Food and Drug Administration (FDA) has released the ...
JD Supra

The Eyes Have It: FDA Approves Phase 1 Clinical Trial of Life Biosciences’ Reprogramming Therapy for Vision Loss

The US Food and Drug Administration (FDA) has approved a Phase 1 clinical trial from Life Biosciences that aims to help certain eye cells act younger and improve vision in glaucoma and related ...
Fierce Biotech

Vertex races to FDA after phase 3 kidney disease data impress analysts

Vertex reported a phase 3 win for its kidney disease prospect povetacicept, meeting analyst expectations and firing the starting gun on a race to the FDA that could result in an accelerated approval ...
Nasdaq

VYNE Therapeutics Inc. Faces FDA Clinical Hold on VYN202 Phase 1b Trial for Plaque Psoriasis

VYNE Therapeutics Inc. has announced that the FDA has placed a clinical hold on its Phase 1b study of VYN202 for moderate-to-severe plaque psoriasis due to observed testicular toxicity in dogs during ...
Nasdaq

4D Molecular Therapeutics Enrolls First Patients in Phase 3 Clinical Trials for 4D-150 in Wet AMD, Receives FDA RMAT Designation for DME

4D Molecular Therapeutics has initiated its first Phase 3 trial for 4D-150 in wet AMD and expanded its clinical pipeline. 4D Molecular Therapeutics (4DMT) has announced significant progress in its ...
The Manila Times

EyePoint Announces First Patients Dosed in Both Global Phase 3 Clinical Trials of DURAVYU™ for the Treatment of Diabetic Macular Edema

Active Phase 3 programs for DURAVYU in wet AMD and DME, the two largest multi-billion-dollar retinal disease markets - ...

Oragenics, Inc.: Oragenics Receives HREC Approval for Phase IIa Clinical Trial of ONP-002 as a Treatment for Concussion and Mild Traumatic Brain Injury in Australia

All required regulatory approvals secured for trial site onboarding and patient enrollment at three Australian sitesPotential first and only pharmacological treatment for the most prominent neurologic ...
Health.com

The 4 Phases of Clinical Trials and How They Work

Carrie Madormo, RN, MPH, is a health writer. She has over a decade of experience as a registered nurse, practicing in a variety of fields, such as pediatrics, oncology, chronic pain, and public health ...

NanoViricides completes manufacturing of NV-387 oral drug ahead of Phase II mpox trial

NanoViricides (NYSE-A:NNVC) said on Wednesday it has completed manufacturing of its NV-387 oral drug product, clearing a key step toward dosing patients in an upcoming clinical trial for mpox. The ...