Nasdaq

Iveric Bio Receives FDA Agreement Under Special Protocol Assessment (SPA) for GATHER2 Phase 3 Clinical Trial of Zimura® in Geographic Atrophy Secondary to Age-Related Macular ...

NEW YORK--(BUSINESS WIRE)-- IVERIC bio, Inc. (Nasdaq: ISEE) today announced that the Company received written agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol ...
FierceBiotech

Amarin Announces FDA Review Division Response to ANCHOR SPA Agreement Reinstatement Request

BEDMINSTER, N.J., and DUBLIN, Ireland, Jan. 21, 2014 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to ...
Nasdaq

BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

NEW YORK, April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it ...
FiercePharma

Amarin Provides Update on ANCHOR Trial SPA Agreement Rescission Appeal

Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of Vascepa on the risk for ...
Yahoo Finance

Oculis Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Optic Neuritis Registrational Trial

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