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News about "Biologics License Application (BLA) "
FYB206 Becomes First Keytruda Biosimilar to Get US FDA Review
The US FDA has accepted FYB206’s Biologics License Application (BLA) for review, marking the first publicly announced Keytruda biosimilar filing acceptance.
Biologics License Application (BLA) | 13/10/2026 | By News Bureau
Pierre Fabre Resubmits Tabelecleucel BLA to FDA
Pierre Fabre Pharmaceuticals resubmits tabelecleucel BLA for treatment of Epstein-Barr virus positive -post-transplant lymphoproliferative disease to the FDA.
Biologics License Application (BLA) | 03/10/2026 | By News Bureau
Fresenius Wins US FDA and EMA Review Acceptance for Vedolizumab Biosimilar
Fresenius has secured US Food and Drug Administration (FDA) and European Medicines Agency (EMA) review acceptance for its vedolizumab biosimilar, targeting Ulcerative Colitis (UC) and Crohn's Disease (CD) in adults.
Biologics License Application (BLA) | 03/08/2026 | By News Bureau | 583
Lilly's Triple Agonist, Retatrutide, Successful in 2 Additional Phase 3 Obesity Trials
Lilly's Triple Agonist, Retatrutide, Successful in 2 Additional Phase 3 Obesity Trials. The company plans to submit a Biologics License Application (BLA) for retatrutide to the US Food and Drug Administration (FDA) in Q1 2027.
Biologics License Application (BLA) | 25/07/2026 | By News Bureau | 138
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 | 201
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 | 193
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 | 422
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 | 352
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