FDA updates Moderna COVID-19 vaccine EUA in bid to speed rollout

Moderna to create vaccine to fight both COVID-19, flu Fox News medical contributor Dr. Janette Nesheiwat says Moderna developments are ‘incredible’ and argues the dual vaccine will very likely ‘save lives.’ The FDA announced two revisions to the emergency use authorization (EUA) granted to Moderna’s COVID-19 vaccine in the hopes…

FDA Approves Zegalogue

FDA Approves Zegalogue (dasiglucagon) Injection for the Treatment of Severe Hypoglycemia in People with Diabetes Copenhagen, DK and Boston, MA, U.S. March 22, 2021 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company aspiring to deliver innovation with novel peptide therapeutics, announced today that the U.S. Food and Drug…

Class I Recall Issued for Some Affinity Pixie Oxygenators

Medtronic is recalling some Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface devices and Perfusion Tubing Packs because of potentially elevated levels of bacterial endotoxin. The single-use cardiotomy/venous reservoir (CVR) is designed to collect and store blood during extracorporeal circulation. The primary blood-contacting surfaces of the CVR are…

Fever Scanners for COVID-19 May Be Inaccurate, FDA Warns

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s  Coronavirus Resource Center. The US Food and Drug Administration (FDA) has issued an alert to consumers, healthcare providers, and other users of thermal imaging systems that measure body temperature that improper use may produce inaccurate readings. The systems have…

Less Risk of Hypoglycemia With Long-Acting Insulin in Elderly

NEW YORK (Reuters Health) – Long-acting insulin analogs may be a safer option than neutral protamine Hagedorn (NPH, also known as isophane insulin) in elderly patients with type 2 diabetes initiating insulin therapy, according to a large observational study. The study, in JAMA Internal Medicine, found that the long-acting insulin…

FDA Grants Emergency Use to Johnson & Johnson COVID-19 Vaccine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. And then there were three. The US Food and Drug Administration (FDA) today granted emergency use authorization (EUA) to the Ad26.COV2.S vaccine from Janssen/Johnson & Johnson (J&J) for people 18 and older after reviewing its safety…

J&J COVID-19 Vaccine Wins Backing of FDA Panel

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. An FDA advisory panel lent their support today to a rapid clearance for Janssen/Johnson & Johnson’s COVID-19 vaccine. The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the…

Janssen/J&J COVID-19 Vaccine Cuts Transmission, New Data Show

Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. New findings suggest the Janssen/Johnson and Johnson COVID-19 vaccine can reduce the risk of an immunized person unknowingly passing along the virus to others. The single-dose vaccine reduces the risk of asymptomatic transmission by 74% at 71 days compared…

Entresto Granted Expanded Indication in Chronic Heart Failure by FDA

EAST HANOVER, N.J., Feb. 16, 2021 — Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto® (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.1 Benefits are most clearly evident in patients with left ventricular…

FDA approves 1st long-acting HIV drug combo, monthly shots

Doctors may have cured second man of HIV Doctors in London performed a bone marrow transplant on the patient and are calling the results ‘long-term remission’; Steve Harrigan reports. U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used…