Tag: Food & Drug Administration
FDA: High Levels of Heavy Metals Found in Kratom Products
Products contain levels of lead and nickel at concentrations that exceed safe daily intake
FDA Approves Mavenclad for Treating Multiple Sclerosis
Treatment indicated for patients with relapsing-remitting, active secondary progressive MS
FDA Grants Approval for Hypogonadism Treatment
Jatenzo indicated for men with low testosterone due to certain conditions
Cimzia Injection Approved for New Inflammatory Arthritis Indication
FDA grants approval for first treatment for nonradiographic axial spondyloarthritis
FDA Approves Mayzent for Relapsing Multiple Sclerosis
Oral medication must be dispensed with important information about the drug's uses and risks
FDA: Breast Density Must Be Reported to Women During Mammograms
Proposed rule would also tighten FDA regulation of mammogram facilities
FDA Panel: Too Early to Ban Breast Implant Linked With Cancer
Evidence growing that certain breast implants can trigger a rare form of lymphoma
FDA: Higher Risk for Death Found With Venclexta in Multiple Myeloma
Enrollment suspended for trials investigating Venclexta for treatment of multiple myeloma
FDA Approves New Device for Chronic, Moderate-to-Severe Heart Failure
Optimizer Smart system indicated for patients who are symptomatic despite optimal medical therapy
FDA: First Treatment Approved Specifically for Postpartum Depression
Zulresso administered by IV infusion over 60-hour period; patients must be monitored during infusion