May 25, 2023

Trientine Reduces NT-proBNP in HFrEF: TRACER-HF Trientine Reduces NT-proBNP in HFrEF: TRACER-HF

In patients with heart failure (HF) and reduced ejection fraction (HFrEF), the copper chelator trientine reduced NT-proBNP levels up to 8 weeks by restoring normal intracellular […]
May 25, 2023

Sulbactam and Durlobactam Injection

  Minimum InhibitoryConcentrations (mcg/mL) Disk Diffusion(zone diameters in mm) Pathogen S I R S I R Acinetobacter-baumannii calcoaceticus complex ≤ 4/4 8/4 ≥ 16/4 ≥ 17 […]
May 25, 2023

Treatment of Depression Reduces Cardiovascular Risk Treatment of Depression Reduces Cardiovascular Risk

Patients who manage their depression through psychological therapy are at reduced risk for cardiovascular diseases. This is the outcome of a large cohort study conducted in […]
May 25, 2023

FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults

For Immediate Release: May 25, 2023 Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral […]
May 25, 2023

From Our Perspective

FDA actions to continue to ensure the safety of the nation’s drug supply By Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research One […]
May 25, 2023

CDER Conversations

CDER Conversation: The Evolving Role of Decentralized Clinical Trials and Digital Health Technologies Decentralized clinical trials and digital health technologies are gaining momentum in medical research, […]
May 25, 2023

Weight Loss Drug Wegovy Can Help Reverse Obesity in 50% of Teens

Share on PinterestHalf of teens taking Wegovy in a recent trial lost enough weight to fall below the threshold for obesity, while a quarter returned to […]
May 25, 2023

Developing Type 2 Diabetes at a Younger Age Increases Dementia Risk

Share on PinterestThe younger a person is when they develop type 2 diabetes, the higher their risk of developing dementia later in life rises. Fertnig/Getty Images […]
May 24, 2023

Study Data Technical Conformance Guide – Technical Specifications Document

Docket Number: FDA-2014-D-0092 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking […]
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