Tag: authorizes

FDA authorizes Roche drug for severely ill COVID-19 patients

COVID vaccines and heart inflammation in young adults a ‘likely’ link: CDC panel Fox News medical contributor Dr. Janette Nesheiwat argues the condition is extremely rare and says vaccine benefits outweigh any potential side effects. The Food and Drug Administration granted emergency approval to Roche’s Actemra (tocilizumab) to boost outcomes among hospitalized COVID-19 patients receiving

FDA authorizes first T cell-based test to detect prior SARS-CoV-2

(HealthDay)—The T-Detect COVID Test, a T cell-based test that helps to identify individuals with recent or prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, was granted emergency use authorization, the U.S. Food and Drug Administration announced Friday. The next-generation sequencing-based test analyzes DNA sequences to identify those with an adaptive T cell immune response

FDA authorizes marketing of ACL implant

(HealthDay)—An anterior cruciate ligament (ACL) implant that offers an alternative to traditional ACL reconstruction has received marketing authorization from the U.S. Food and Drug Administration—the first approval for an ACL tear treatment in more than 30 years, the agency announced yesterday. The Bridge-Enhanced ACL Repair (BEAR) Implant received approval under the De Novo premarket review