FDA authorizes marketing of EndoRotor system

The U.S. Food and Drug Administration granted marketing authorization to the EndoRotor System, which provides a minimally invasive way to resect and remove necrotic tissue for patients with walled-off pancreatic necrosis (WOPN), the agency announced last week. The approval provides a new treatment option for the estimated 15 percent of…

FDA authorizes first COVID-19 test for self-testing at home

Yesterday afternoon, the U.S. FDA issued an Emergency Use Authorization (EUA) to a COVID-19 molecular diagnostic test that provides individuals with a result within 30 minutes, in the comfort of their home. As opposed to currently available at-home testing products, which have patients self-collect a nasal swab sample and ship…

FDA Approves Bronchitol

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis CARY, N.C., Nov. 02, 2020 (GLOBE NEWSWIRE) — Chiesi USA, Inc., the U.S. affiliate of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), received U.S. Food and Drug Administration (FDA) approval of…

Why the FDA just issued another hand sanitizer recall

With all the COVID-related matters we’re dealing with right now, we probably didn’t need the news that the FDA is recalling even more hand sanitizers, yet here we are. The government agency is warning that 1-propanol is now showing up in hand sanitizers.  The FDA says: “1-propanol, not to be confused with…

FDA finds contamination in several brands of diabetes drug

U.S. health regulators are telling five drugmakers to recall their versions of a widely used diabetes medication after laboratory tests found elevated levels of a contaminant linked to cancer. The Food and Drug Administration said late Thursday that several batches of the drug metformin tested positive for unsafe levels of…

FDA labeling restriction quickly reflected in oncology practice

(HealthDay)—The June 2018 U.S. Food and Drug Administration label restriction on first-line immunotherapy for advanced bladder cancer was associated with a decrease in immunotherapy use and an increase in chemotherapy use, according to a research letter published in the Sept. 24 issue of the Journal of the American Medical Association….

FDA warns of infections from fecal transplants after 1 death

(HealthDay)—Fecal transplants—transferring fecal matter from a healthy person into an ill person with a compromised “microbiome”—is an increasingly used new treatment for a variety of ills. But on Thursday federal health officials announced that a patient died after such a procedure, highlighting the potential for severe infections linked to fecal…