Tag: Food & Drug Administration
Kerendia Approved for Heart Failure With Left Ventricular Ejection Fraction ≥40 Percent
Patients taking Kerendia saw significant reduction in cardiovascular death and hospitalization and urgent visits for heart failure
FDA Publishes Full Texts of Response Letters to Drug Applications
The goal is to improve public understanding of the FDA decision-making process
FDA Approves Monjuvi for Relapsed, Refractory Follicular Lymphoma
Significantly improved progression-free survival seen with Monjuvi in combination with rituximab and lenalidomide
FDA Offers Speedier Approvals to Drug Companies Aligning With ‘National Priorities’
Agency is offering vouchers to some drug manufacturers to shorten review time for final drug applications
CDC, FDA Warn of Salmonella Outbreak Linked to Pistachio Cream
Four individuals across two states have been sickened and one person has been hospitalized
FDA Plans to Use AI to Speed Up Drug and Food Safety Reviews
By I. Edwards HealthDay Reporter
WEDNESDAY, June 11, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) says it plans to use artificial...
FDA Authorizes First AI Platform for Breast Cancer Prediction
Platform can help predict a woman's five-year risk for developing breast cancer by analyzing routine mammograms
Moderna’s New Lower-Dose COVID-19 Vaccine Approved by FDA
New vaccine represents a step forward in development of next-generation coronavirus vaccines
FDA Issues Highest Alert Over Tomato Recall in 3 Southern States
By I. Edwards HealthDay Reporter
MONDAY, June 2, 2025 (HealthDay News) — Salmonella-tainted tomatoes in three southern states could cause severe illness or even death,...
FDA Chief: COVID Vaccine in Pregnancy Should Be Personal Choice
By I. Edwards HealthDay Reporter
FRIDAY, May 30, 2025 (HealthDay News) — Federal health officials have pulled back a key recommendation that pregnant women get...
