Items related to biologics will be added to the top of the list as they are posted on the site.
7/11/2025 Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment; Draft Guidance for Industry 7/10/2025 July 9, 2025 Approval Letter - SPIKEVAX 7/7/2025 July 1, 2025 Approval Letter - FLULAVAL 7/7/2025 July 3, 2025 Approval Letter - MNEXSPIKE 7/3/2025 July 1, 2025 Approval Letter - AFLURIA 7/3/2025 May 23, 2025 Clinical Review Memo - MenQuadfi 7/3/2025 May 21, 2025 Statistical Review - MenQuadfi 7/2/2025 Complete List of Licensed Products and Establishments Update7/2/2025 Complete List of Substantially Equivalent 510(k) Device Applications Update7/2/2025 Complete List of Currently Approved Premarket Approvals (PMAs) Update7/2/2025 Complete List of Currently Approved NDA and ANDA Application Submissions Update7/2/2025 June 26, 2025 Approval Letter - KYMRIAH 7/2/2025 July 1, 2025 Approval Letter - Flublok 7/2/2025 July 1, 2025 Approval Letter - FLUAD 7/2/2025 BK251233 - cobas HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas 5800/6800/8800 systems 7/2/2025 July 1, 2025 Approval Letter - Fluzone and Fluzone High-Dose 7/2/2025 July 1, 2025 Approval Letter - FLUCELVAX 7/2/2025 Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry 7/1/2025 July 1, 2025 Approval Letter - FluMist 6/30/2025 June 27, 2025 Approval Letter - GAMMAGARD LIQUID 6/30/2025 June 26, 2025 REMS Elimination Approval Letter – TECARTUS 6/30/2025 June 26, 2025 REMS Elimination Approval Letter – YESCARTA 6/27/2025 June 26, 2025 Approval Letter - TECARTUS 6/27/2025 June 26, 2025 Approval Letter - YESCARTA 6/27/2025 Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff 6/27/2025 June 26, 2025 Approval Letter - ABECMA 6/26/2025 FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies 6/26/2025 June 26, 2025 Approval Letter - CARVYKTI 6/25/2025 June 25, 2025 Approval Letter - SPIKEVAX 6/25/2025 BK251184 - DG Gel 8 Neutral card 6/25/2025 BK251183 - Erytra 6/25/2025 BK251182 - Erytra Eflexis 6/25/2025 June 25, 2025 Approval Letter - COMIRNATY 6/25/2025 FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination 6/24/2025 FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS 6/24/2025 June 23, 2025 Approval Letter - FIBRYGA 6/23/2025 BK241079 - Peripheral blood processing device for wound management 6/20/2025 May 30, 2025 Summary Basis for Regulatory Action - MNEXSPIKE 6/20/2025 June 17, 2025 Approval Letter - Anti-Human Globulin DG GEL 8 ANTI-IgG (Rabbit) - STN# 125445/74 6/18/2025 May 14, 2025 Approval Letter - PRIVIGEN
Content current as of:
07/11/2025