This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval.

2026 Biological License Application Approvals

Tradename/Proper Name

Indication for Use

STN

Manufacturer/
License Number

Approval Date

KRESLADI

marnetegragene autotemcel

Indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency-I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant.

125806/0

Rocket Pharmaceuticals, Inc.

9 Cedarbrook Drive
Cranbury, NJ 08512

Lic. # 2328

03/26/2026

Procleix Plasmodium Assay

Intended for use in screening individual human donors, including donors of whole blood and blood components, and in screening living donors of organ and tissue samples when specimens are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens. Whole blood donor samples are tested individually.

125862/0

Grifols Diagnostic Solutions, Inc.

10804 Willow Court San Diego, CA 92127

Lic. # 2032

03/16/2026

Content current as of:

05/01/2026

Source

Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.

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