Monday, June 30, 2025

June 30, 2025 at 08:29PM GAMMAGARD LIQUID

Product approval information is indicated for:
• Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
• Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

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June 27, 2025 at 11:17PM MNEXSPIKE

For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
MNEXSPIKE is approved for use in individuals who have been previously vaccinated with any COVID-19 vaccine and are:
• 65 years of age and older, or
• 12 thro

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June 27, 2025 at 10:16PM FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

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June 27, 2025 at 08:56PM TECARTUS

For the treatment of adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B-ALL). For the treatment of adult patients with relapsed/refractory mantle cell lymphoma (r/r MCL).

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June 27, 2025 at 07:50PM YESCARTA

For the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma.

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June 27, 2025 at 04:10PM ABECMA (idecabtagene vicleucel)

ABECMA is the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

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Thursday, June 26, 2025

June 27, 2025 at 01:42AM FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies

The REMS for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies have been eliminated because the FDA has determined that a REMS is no longer necessary.

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June 26, 2025 at 03:43PM Unique Device Identifier Requirements for Combination Products

Draft guidance to assist industry and FDA staff in understanding how FDA’s unique device identifier (UDI) requirements apply to combination products with device constituent parts, and outline requirements and recommendations for UDI labeling and submission of information to the GUDID database

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June 26, 2025 at 03:42PM Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficien

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June 26, 2025 at 02:20PM mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

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Wednesday, June 25, 2025

June 25, 2025 at 09:52PM Labeling for CBER-Regulated Products

Labeling for CBER-Regulated Products

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June 25, 2025 at 07:36PM FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination

FDA has required and approved updates to the Prescribing Information for Comirnaty manufactured by Pfizer Inc. and Spikevax manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines.

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Tuesday, June 24, 2025

June 24, 2025 at 04:59PM Laboratory Information Bulletins

Laboratory Information Bulletins available to the public

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June 24, 2025 at 01:00PM Questions about Vaccines

Information on general and specific vaccines

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Wednesday, June 18, 2025

June 18, 2025 at 04:17PM PRIVIGEN

For the treatment of:

Primary humoral immunodeficiency (PI)

Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and older

Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults

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Friday, June 13, 2025

June 13, 2025 at 06:15PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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June 13, 2025 at 02:48PM FDA Rare Disease Innovation Hub

FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.

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Thursday, June 12, 2025

June 12, 2025 at 09:24PM 2025 Biological License Application Approvals

Listing of the 2025 Biological License Application Approvals

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June 12, 2025 at 04:34PM Compliance Programs (CBER)

List of biological CBER compliance programs

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June 10, 2025 at 04:29PM ABRYSVO

ABRYSVO is an active immunization for the prevention of LRTD caused by RSV

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June 10, 2025 at 02:55PM Seasonal Information for Influenza Virus Vaccine

Seasonal Information for Influenza Virus Vaccine

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