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 ...
Ophthalmology Times

Harrow receives FDA IND clearance for phase 3 trial of TRIESENCE after cataract surgery

FDA IND clearance enables a phase 3 program evaluating TRIESENCE for postoperative ocular inflammation and pain following cataract surgery, aiming to broaden on-label use beyond current intraocular ...
Healio

FDA clears NexEos Bio IND application for NTX-1024 in vernal keratoconjunctivitis

The FDA cleared an investigational new drug application for NTX-1024 ophthalmic solution in vernal keratoconjunctivitis, ...

Daré Bioscience Announces FDA Clearance of IND for Phase 2 Clinical Study of DARE-HPV, a Potential Treatment for Persistent High-Risk HPV Infection, the Most Common Cause of ...

Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced ...
Morningstar

Cartography Receives FDA Investigational New Drug (IND) Approval and Fast Track Designation for Lead Program CBI-1214 for Colorectal Cancer

Cartography Biosciences, Inc., a biotechnology company advancing a differentiated pipeline of antibody-based cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has ...
JD Supra

Let It Grow: FDA Revises Q&A Guidance to Support Sponsors With the Implementation of Expanded Access Programs

“Let it grow, let it blossom,” said Eric Clapton, and so the Food and Drug Administration expects of expanded access programs with the issuance of its guidance on “Expanded Access to Investigational ...