Archive for February, 2021

FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older

Today, the U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive sleep apnea. Unlike…

FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma

Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell…

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to…

Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants

As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines…