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Last updated 2 days ago
FDA approves imlunestrant in combination with abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
2 days ago
On September 18, 2026, the Food and Drug Administration approved imlunestrant (Inluriyo)...
FDA Approves Therapy to Treat Ataxia in Patients with Ataxia-Telangiectasia, a Rare Genetic Disorder
2 days ago
FDA has approved Aqneursa (levacetylleucine) for oral suspension to treat ataxia in...
Project Orbis
2 days ago
Information Project Orbis, an initiative of the FDA Oncology Center of Excellence...
New Approach Methodologies (NAMs) Database of Use Case Examples
2 days ago
Explore practical examples of New Approach Methodologies (NAMs) described in publicly available...
CDER Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)
2 days ago
CDER's primary focus is ensuring the safety and efficacy of human drugs...
Data Standards Program Strategic Plan and Board
3 days ago
The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation...
FDA Public Workshop: Future Needs for the Development of Interchangeable Products - 09/19/2025
3 days ago
The public meeting will be held on September 19, 2025, from 9...
Human Drug Compounding
3 days ago
Compounded drugs can serve an important medical need for certain patients, they...
Drug Safety Oversight Board (DSB) Meeting June 26, 2024
3 days ago
Public Summary for June 26, 2024 Drug Safety Oversight (DSB) Meeting. This...