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May 18, 2023

Spotlight on CDER Science

The Role of Disclosures: Helping to Understand Oncology Clinical Trial Endpoints Clinical endpoints are measurable events or outcomes that can help determine whether a medical intervention, […]
May 18, 2023

The Role of Disclosures: Helping to Understand Oncology Clinical Trial Endpoints

FDA Research Focused on Direct-to-Consumer Television Advertising Clinical endpoints are measurable events or outcomes that can help determine whether a medical intervention, such as a therapy, […]
May 18, 2023

Lymol Medical Corp – 570153 – 01/08/2019

WARNING LETTER Jan 8, 2019 VIA UNITED PARCEL SERVICE Ref:#19-HFD-45-01-01 Lymol Medical Corporation Attention: Kim Abrano, Chairman & CEO 4 Plympton Street Woburn, MA 01801 Dear […]
May 18, 2023

Age-Specific Cut-Offs Needed for Cardiac Troponin Tests? Age-Specific Cut-Offs Needed for Cardiac Troponin Tests?

Using age-specific thresholds for troponin measurement would more accurately diagnose myocardial injury when assessing patients for suspected myocardial infarction (MI), a new study suggests. The study […]
May 18, 2023

Barox Co., Ltd. – 565314 – 11/28/2018

Product: Drugs Recipient: Recipient Name Mr. Hak-Ki Kim Recipient Title President Barox Co., Ltd. Number 706, HallaSigma, 545, Dunchon-DaeroJungwon-gu, Gyeonggi-doSeongnam13215South Korea Issuing Office: Center for Drug […]
May 18, 2023

Overdose Deaths Mark Another Record Year, but Experts Hopeful Overdose Deaths Mark Another Record Year, but Experts Hopeful

The surge in drug overdose deaths in the U.S. during the first 2 years of the pandemic appears to have stabilized, according to newly released figures […]
May 18, 2023

Evidence of TAVR Benefit Extends to Cardiogenic Shock Evidence of TAVR Benefit Extends to Cardiogenic Shock

For patients undergoing transcatheter aortic valve replacement (TAVR), adverse outcomes are more common in those who are in cardiogenic shock than those who are not, but […]
May 18, 2023

Patritumab Deruxtecan Shows Promise for Breast Cancer Patritumab Deruxtecan Shows Promise for Breast Cancer

A single dose of a new antibody-drug conjugate known as patritumab deruxtecan provoked a response in nearly one-third of patients with HR-positive/HER2-negative or triple-negative breast cancer, according […]
May 18, 2023

Half of Teens Drop Below Obesity Cutoff With Semaglutide Half of Teens Drop Below Obesity Cutoff With Semaglutide

DUBLIN — Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the […]
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