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Last updated about 11 hours ago
Public Meeting: FDA Rare Disease Day 2026 - 02/23/2026
about 11 hours ago
FDA will host Rare Disease Day, a virtual public meeting, on Monday...
Lux Therapeutics LLC dba Ponya Therapeutics LLC - 720001 - 11/25/2025
7 days ago
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
BioXtek LLC - 715478 - 12/01/2025
7 days ago
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc - 681480 - 12/01/2025
7 days ago
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers
7 days ago
The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms)...
FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
7 days ago
FDA approved and authorized for emergency use updated COVID-19 vaccines formulated to...
FDA Roundup: May 31, 2024
7 days ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Roundup: March 12, 2024
7 days ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Roundup: January 7, 2025
7 days ago
The U.S. Food and Drug Administration is providing an at-a-glance summary of...
FDA Approves First COVID-19 Vaccine
7 days ago
FDA approved the first COVID-19 vaccine, which has been known as the...