JOHANNESBURG (Reuters) – South Africa has suspended the rollout of Johnson & Johnson’s (J&J) COVID-19 vaccine, its health minister said on Tuesday, after U.S. federal health agencies recommended pausing its use because of rare cases of blood clots. The U.S. Food and Drug Administration (FDA) said the pause there was expected to be a matter […]
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) today recommended that healthcare facilities cut back on the use of strategies for conserving capacity that have been in effect during the COVID-19 crisis, such as decontaminating disposable respirators for reuse. The National Institute […]
Ruxolitinib cream, an investigational selective Janus kinase 1 and 2 inhibitor now under priority review by the Food and Drug Administration for the treatment of atopic dermatitis (AD) down to age 12 years, demonstrated a dual mechanism of action in two pivotal phase 3 trials: antipruritic and anti-inflammatory, Kim A. Papp, MD, PhD, said at […]
US regulators are stepping up scrutiny of cancer indications that were granted an accelerated approval on the basis of surrogate endpoints but that have failed to show clinical or survival benefits on more extensive testing. At issue are a number of cancer indications for immunotherapies. Four have already been withdrawn (voluntarily by the manufacturer), and […]
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 guidance warning consumers against using the antiparasitic drug ivermectin to treat or prevent COVID-19. The agency says it issued the guidance on Friday in light of growing interest in the drug as […]
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Moderna completed manufacturing a version of its vaccine to prevent infection by B.1.351, a variant first identified in South Africa. The company is sending doses of this mRNA-1273.351 booster vaccine to the National Institutes of Health (NIH) for evaluation in a […]
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The United States might possibly have a surplus of COVID-19 vaccines available later this year, with production increasing and new shots advancing to emergency clearances, pharmaceutical executives said at a House hearing on Tuesday. The House Energy and Commerce Committee’s investigations […]
