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News about "Biologics License Application (BLA) "
Opus Genetics Aligns with US FDA on Phase 3 OPGx-LCA5 Trial
Opus Genetics has aligned with the US Food and Drug Administration (FDA) on the Phase 3 trial design for OPGx-LCA5 in inherited retinal disease, with phase 3 dosing expected in Q4 2026 and a potential Biologics License Application (BLA) submission based on 6-month efficacy data.
Biologics License Application (BLA) | 07/07/2026 | By News Bureau
IMUNON Reports Phase 2 Data Showing Improved Survival in Advanced Ovarian Cancer
IMUNON reports updated Phase 2 data showing improved Overall Survival (OS) with IMNN-001 in advanced ovarian cancer.
Biologics License Application (BLA) | 26/03/2026 | By News Bureau | 110
FDA Approves Waskyra Gene Therapy for Wiskott-Aldrich Syndrome
Fondazione Telethon announced that the US FDA has approved Waskyra (etuvetidigene autotemcel), a gene therapy for Wiskott-Aldrich Syndrome (WAS), marking a milestone in both science and clinical care. The approval offers new hope for patients living with this rare immunodeficiency disorder.
Biologics License Application (BLA) | 11/12/2025 | By Akanki | 312
AbbVie has begun a USD 70 million expansion of its AbbVie Bioresearch Center (ABC) in Worcester, Massachusetts, and broken ground on a new North Chicago Active Pharmaceutical Ingredient (API) manufacturing facility.
Biologics License Application (BLA) | 01/10/2025 | By Dineshwori | 295
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