News

The FDA regularly posts updates on recalls, outbreak investigations, and related regulatory activities. Weekly, we identify which of those announcements might be most clinically relevant.

FDA expands usage to all hospitalized COVID-19 patients.

The 15-minute test was granted emergency authorization by the FDA earlier this week.

John F. Kokai-Kun, PhD, explains the supply chain and logistical issues limiting the scale of monoclonal antibody treatment.

John F. Kokai-Kun, PhD, Director of External Scientific Collaboration at US Pharmacopeia, explains the fundamentals of monoclonal antibody treatment.

A new report suggests a personalized approach to sepsis treatment, recommending prompt antimicrobial therapy for the sickest patients and a more personalize approach for those with less severe cases.

The short-lived designation of remdesivir as an Orphan Drug to treat COVID-19 exposed loophole in the Orphan Drug Act.

How can critically ill COVID-19 patients experience immune system “paralysis” when inflammatory processes are in overdrive?

Hospital admissions for stroke fell by nearly a third during March and April 2020 alone when compared with those months in 2019.

Martin Kulldorff, PhD, explains that masks can't replace social distancing for those at highest risk for severe COVID-19.

A systematic review and meta-analysis was undertaken to ascertain optimal route and duration of antibiotic treatment of acute cellulitis

Drug has shown promise in COVID-19, but other, oral options are needed.

The device has test result features likened to pregnancy tests, and can be produced vastly every month.

Brad Spellberg, MD, explains how real progress can be made to a debted system with worsened rates of user health.

Martin Kulldorff, PhD, answers whether an age based coronavirus strategy would worsen the pandemic's impact on workers and minority racial groups.

Investigators report comparable SARS-CoV-2 neutralizing antibody counts across age groups, as well as favorable safety outcomes for the two-dose vaccine.

Soon after visiting 38 hospitals in Michigan, over half of patients hospitalized with suspected COVID-19 received antibiotics.

The US Centers for Disease Control and Prevention has updated COVID-19 guidance, sharing advice on safe travel

ARCC made the announcement yesterday that the WHO African Region is free of the virus.

ViiV Healthcare’s dolutegravir/lamivudine (Dovato) may be potential treatment option for this patient population

Hospitals considering interventions to reduce Clostridioides difficile infections may find that less is more, according to a new study that found daily cleaning with sporicidal products to be the most cost-effective single infection control strategy.

John Johnson, lead for Ebola vaccination with MSF France, describes the "ring strategy" used in controlling several infectious disease threats.

Martin Kulldorff, PhD, takes a total social health perspective on the global use of mass quarantines as a primary COVID-19 control strategy.

Brad Spellberg, MD, discusses how the subspecialty lost "ownership" of its opportunities for pattented prescribing and referral years ago.

Company says investigational therapeutic could afford at least 6 months of protection from the virus.

Incomplete data tells only half the story, and this story is devastating.

This could be an important feature in potential vaccine development.

Regeneron will distribute a prospective therapy in the US and Roche will be responsible for it internationally.