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Latest posts
Last updated about 1 hour ago
Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned - 09/23/2025
about 1 hour ago
Opening Remarks by Sara Brenner, U.S. Food and Drug Administration September 23...
Center for Drug Evaluation and Research Organization Chart
about 2 hours ago
Organization chart for the FDA's Center for Drug Evaluation and Research, including...
Artificial Intelligence for Drug Development
3 days ago
FDA recognizes the increased use of AI throughout the drug development process...
External Engagements with FDA for Artificial Intelligence in Drug Development
3 days ago
To discuss the use of AI in connection with a specific development...
FDA works to protect consumers from potentially harmful OTC skin lightening products
3 days ago
FDA works to protect consumers from potentially harmful OTC skin lightening products
FDA approves vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
3 days ago
FDA approves vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
3 days ago
FDA is announcing that it issued a “safe to proceed” letter to...
Ongoing | Cancer Accelerated Approvals
3 days ago
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...
Drug Trials Snapshot: TRYNGOLZA
3 days ago
TRYNGOLZA is a prescription medicine (an APOC-III-directed antisense oligonucleotide) that is used...
Drug Trials Snapshot: ALYFTREK
3 days ago
ALYFTREK is a medication for the treatment of cystic fibrosis (CF) in...
Drug Trials Snapshot: ROMVIMZA
3 days ago
The FDA approved ROMVIMZA based on safety and efficacy evidence from one...