2026 Biological License Application Supplement Noteworthy Approvals

This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed by date of approval, with the most recent action at the top.

2025 Biological License Application Supplement Noteworthy Approvals

Tradename/Proper Name	Indication for Use	STN	Manufacturer/ License No.	Approval Date
COMIRNATY COVID-19 Vaccine, mRNA	To revise the Package Insert to include information in Section 8 Use in Specific Populations from Study C4591015 of COMIRNATY administered during pregnancy (with the first dose at 24 to 34 weeks gestation) and from Study C4591024 of COMIRNATY administered to immunocompromised individuals 5 years of age and older.	125742/684	BioNTech Manufacturing GmbH Pfizer, Inc. 66 Hudson Boulevard East New York, NY 10001 Lic. # 2229	02/20/2026
BREYANZI lisocabtagene maraleucel	To fulfill the BL 125714/225 accelerated approval required study, final milestone, and to provide evidence of effectiveness necessary to support the conversion from an accelerated approval to a traditional approval of lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.	125714/703	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company 556 Morris Avenue Summit, NJ 07901 Lic. # 2156	02/20/2026
SHINGRIX Zoster Vaccine Recombinant, Adjuvanted	To include revisions to the Package Insert as follows: Section 6.2 Postmarketing Experience, General Disorders and Administration Site Conditions: to include “injection site induration” Section 6.2 Postmarketing Experience, Postmarketing Observational Studies of the Risk of GuillainBarré syndrome following Vaccination with SHINGRIX: to include information from Study EPI-ZOSTER-032 regarding the risk of Guillain-Barre syndrome during 42 days after SHINGRIX vaccination Section 16.1 SHINGRIX Vial and Vial Presentation: to remove reference to the vial and vial presentation supplied in a one-dose carton	125614/1206	GlaxoSmithKline Biologicals 14200 Shady Grove Road VR1500 Rockville, MD 20850-7640 Lic. # 1617	02/13/2026
YESCARTA  axicabtagene ciloleucel	The supplement revises United States Prescribing Information (USPI) as follows: Section 1 (Indication and Usage) removes the Limitations of Use for Primary Central Nervous System Lymphoma (PCNSL); Section 5 (Warnings and Precautions) adds neurological toxicities identified from the new clinical study; Section 6 (Adverse Reactions) incorporates study information and adverse reactions from the new clinical study; and Section 12.3 (Pharmacokinetics) adds pharmacokinetics data from the new clinical study.	125643/753	Kite Pharma, Inc. 2400 Broadway Santa Monica, CA 90404 Lic. # 2064	02/05/2026