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Grace Halsey
Articles
Sotagliflozin in Patients with Type 1 Diabetes and CKD to be Discussed at October FDA AdComm Meeting
October 14, 2024
Lexicon's sotagliflozin is on the October 31 docket for discussion by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee; PDUFA goal date remains set for December 20.
Elinzanetant Update: FDA Accepts Bayer NDA, Sets July 2025 PDUFA Date
October 11, 2024
The elinzanetant NDA is based on data, including long-term efficacy, from the OASIS phase 3 clinical trial program, according to Bayer.
Researcher Explains How Women Respond to a False Positive Breast Cancer Screening Result
October 11, 2024
After a false positive outcome on screening mammography, a short interval call back for repeat imaging was a significant deterrent to future screening.
Single vs Multiple Inhaler Triple Therapy for COPD Could Triple Adherence, Persistence: International Data
October 11, 2024
CHEST 2024: Combined data from 4 continents found consistently better adherence/persistence when COPD triple therapy was initiated with a single inhaler.
Early Identification, Treatment of COPD Reduces Exacerbations, Health Care Burden
October 10, 2024
CHEST 2024. Initial treatment for people with COPD should begin early in the disease and leads to significantly reduced risk for exacerbations and inpatient treatment.
The Potential Harms of Breast Cancer Screening Need to be Explored and this Biostatistician is All In
October 10, 2024
The most common harm associated with breast cancer screening is a false positive finding; this UC Davis expert wanted to know more about how women respond.
Ensifentrine, Novel PDE3, PDE4 Inhibitor, Improves Lung Function, QoL Regardless of COPD Severity
October 09, 2024
The combined bronchodilator/anti-inflammatory agent significantly improved lung function, symptoms and QoL in adults with moderate or severe airflow obstruction.
New Data for Arexvy Show Vaccine Efficacy Through 3 RSV Seasons in Older Adults
October 09, 2024
Data on adults aged 60 years and older who received a single dose of the RSV vaccine indicate safety and reactogenicity consistent with the overall GSK phase 3 trial program.
FDA Black-Box Warnings on Antidepressants Linked to Reduced Treatment, Increased Risk of Suicide Among Youth
October 08, 2024
The FDA warnings were intended to increase physician monitoring for suicidal thoughts and behaviors but have had dramatic unintended consequences.
FDA Grants Marketing Authorization to First OTC Flu/COVID-19 Test Outside Emergency Use Declaration
October 08, 2024
The non-prescription test has more than 95% sensitivity and specificity for SARS-COV-2 and influenza A and B and delivers results in approximately 15 minutes.