Archive for March, 2021

Coronavirus (COVID-19) Update: March 30, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The agency has updated…

FDA Allows for First Point-of-Care  Chlamydia and Gonorrhea Test to be Used in More Near-Patient Care Settings

Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as…

FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma

The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded…

Coronavirus (COVID-19) Update: March 26, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On March 23, 2021,…

FDA Authorizes Marketing of Device to Improve Gait in Multiple Sclerosis Patients

Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use as a short-term treatment of gait deficit due to…

FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease

Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native…

FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients

Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to…

Coronavirus (COVID-19) Update: March 23, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: In a March 22…

FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief

The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate…

Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device…