Merck’s oral COVID treatment molnupiravir lacks adequate evidence to support claims that it’s any more effective than symptomatic care. Read More

The technologies are also made available through the World Health Organization’s COVID-19 Technology Access Pool (C-TAP) program. Read More

The plant has produced more than 200 million doses of COVID-19 vaccines. Read More

In the wake of strongly positive data and an FDA go-ahead, Veru will seek an Emergency Use Authorization (EUA) for sabizabulin, its investigational COVID-19 therapy. Read More

Spikevax is not currently authorized or approved for children under 18. Read More

The troubled manufacturing plant Emergent BioSolutions concealed proof of quality problems at its Baltimore, Md., location just a month and a half before it told the FDA that 15 million COVID-19 vaccine doses manufactured there had been contaminated. Read More

False positive results could lead to further exposure of uninfected individuals to the SARS-CoV-2 virus, the agency said. Read More

The UK currently permits people over age 75 and people who are immunosuppressed to get the fourth COVID-19 vaccine shot. Read More

In a May 6 briefing before Congress, the director of the FDA’s Center of Biologics Evaluation and Research (CBER), Peter Marks, said the agency would not withhold authorization for a pediatric vaccine solely because it did not reach a 50 percent efficacy threshold at blocking symptomatic infection — a requirement that had been previously listed in FDA guidance. Read More

Raoult denied the gravity of the IHU’s practices. Read More

The swabs work with a variety of automated decappers to create hands-free workflows. Read More

No false positive or negative test results were reported, the company said. Read More