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What's New: Drugs RSS Feed

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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 Snapshots: DATROWAY

3 days ago

Drug Trials Snapshots: DATROWAY

Drug Trials Snapshot: ROMVIMZA

3 days ago

The FDA approved ROMVIMZA based on safety and efficacy evidence from one...