FDA · Feed
Biologics
21 signals · sorted by published date
3h ago
Biologics/Update
· 3h agoConsumer Updates
FDA Vaccines, Blood & Biologics
—
Medium
3h agoBiologics/Update
· 3h agoDrugs@FDA Data Files
FDA Center for Biologics Evaluation and Research (CBER)
FDA Center for Biologics Evaluation and Research (CBER)
Medium
4h agoBiologics/Update
· 4h agoWhat’s New for Biologics
N/A - Source provides limited detail
N/A - Source provides limited detail
Low
4h agoBiologics/Update
· 4h agoIs It Really 'FDA Approved'?
FDA Vaccines, Blood & Biologics
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Medium
4h agoBiologics/Update
· 4h agoRegulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products - 05/19/2026
Drug manufacturers, Device manufacturers
Drug manufacturers, Device manufacturers
Medium
2d agoBiologics/Update
· 2d agoArtificial Intelligence for Drug Development
Sponsors utilizing AI/ML tools in drug development
Sponsors utilizing AI/ML tools in drug development
Medium
2d agoBiologics/Update
· 2d ago2026 Biological License Application Approvals
Source does not list specific companies
Source does not list specific companies
Medium
3d agoBiologics/Update
· 3d agoOTP Events, Meetings, and Workshops
FDA Vaccines, Blood & Biologics
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Medium
3d agoBiologics/Update
· 3d agoPatient Listening Session Summaries
Manufacturers of biologic therapies
Manufacturers of biologic therapies
Medium
3d agoBiologics/Update
· 3d agoPublic Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma - 05/12/2026
Blood Establishments, Source Plasma Manufacturers
Blood Establishments, Source Plasma Manufacturers
Medium
4d agoBiologics/Update
· 4d agoVaccines and Related Biological Products Advisory Committee March 12, 2026 Meeting Announcement - 03/12/2026
Influenza Vaccine Manufacturers
Influenza Vaccine Manufacturers
Medium
4d agoBiologics/Update
· 4d agoOTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products - 06/04/2026
FDA Vaccines, Blood & Biologics
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Medium
4d agoBiologics/Update
· 4d agoGAMUNEX-C
Grifols Therapeutics LLC
Grifols Therapeutics LLC
Medium
5d agoBiologics/Update
· 5d agoBiologics Electronic Reading Room (eFOIA)
FDA Vaccines, Blood & Biologics
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Low
5d agoBiologics/Update
· 5d agoCommissioner's National Priority Voucher (CNPV) Pilot Program
FDA Vaccines, Blood & Biologics
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High
6d agoBiologics/Update
· 6d agoLabeling and Promotion Guidances
FDA Vaccines, Blood & Biologics
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Medium
6d agoBiologics/Update
· 6d agoDevices Guidances
CBER-regulated entities
CBER-regulated entities
Low
6d agoBiologics/Update
· 6d agoCMC and GMP Guidances
FDA Vaccines, Blood & Biologics
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Medium
1w agoBiologics/Press Release
· 1w agoFDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
Not specified in source excerpt
Not specified in source excerpt
High
2w agoBiologics/Guidance
· 2w agoFDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
Sponsors of human gene therapy products
Sponsors of human gene therapy products
High
Mar 26, 2026Biologics/Approval
· Mar 26, 2026FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I
Rocket Pharmaceuticals
Rocket Pharmaceuticals
High