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Fierce Biotech The FDA seems to be satisfied that Pfizer’s RSV vaccine is safe and effective for administration in pregnant women to protect infants from severe disease. The agency’s confidence was revealed in briefing documents filed ahead of an advisory committee meeting set for Thursday. The Vaccines and Related Biological Products Advisory Committee will consider […]

Trial Site News The World Health Organisation (WHO) decided Thursday May 4, 2023, to end the COVID-19 public health emergency of international concern (PHEIC). TrialSite cautions that this is a provisional (temporary) status while WHO considers its forward-looking options (2023-2025). Importantly, in “The COVID-19 Emergency is Over, Sort of,” TrialSite reports that in America some […]

Mayo Clinic Clinical trials advance medicine, but the National Institutes of Health says that more than half of studies are unable to recruit or retain the necessary research participants, which can exacerbate health disparities. However, in recent years, digital technologies have helped trials become more accessible and inclusive. Clinical trials are moving out of traditional research facilities and […]

Applied Clinical Trials As with another oft-mentioned path, the road leading to regulatory approval is paved with good intentions. Clinical trials testing molecules once deemed to be of financial and medical value can, metaphorically at least, be found stacked up outside the regulator’s door. The many factors that halt a trial’s successful progress are a […]