Antifungal Susceptibility Test Interpretive Criteria
Antifungal Susceptibility Test Interpretive Criteria
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
Learn about the FDA’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) designed to curb opioid misuse by ensuring safe…
October – December 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
This report lists potential signals of serious risks/new safety information that were identified using the FAERS database during October –…
Resource Capacity Planning and Modernized Time Reporting
FDA is making optimal use of its financial resources to maximize its ability to efficiently and effectively deliver on its…
Sani-Care Salon Products, Inc. – 673747 – 04/24/2024
CGMP/Finished Pharmaceuticals/Adulterated
Investigations Into Structures of In Vitro–Derived Phase I Metabolites of a Novel 20‐Keto‐Steroid S42 by GC‐EI HR MS Analysis and Chemical Synthesis
A set of mono-hydroxylated S42 derivatives S42-C20-OH, S42-C6ß-OH, and S42-C7α-OH were synthesized and investigated by GC-EI HR MS. These compounds…
FDA approves durvalumab for muscle invasive bladder cancer
On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment,…
FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors
Today, the U.S. Food and Drug Administration approved a novel treatment for hemophilia A or B, with or without factor…
Scientific Public Private Partnerships and Consortia
Find out how CDER works with partners and consortia to identify science gaps in drug development
FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication
On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis…