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In prepared remarks at a Senate hearing today, National Institutes of Health Director Francis Collins is expected to say that there is “growing optimism” that one of the multiple COVID-19 vaccine candidates will prove safe and effective by late 2020 or early 2021. Read More
The FDA cited Fresenius Kabi following an inspection of its Melrose Park, Illinois plant that revealed multiple deficiencies, including a failure to properly deal with product contamination. Read More
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has called for revoking the marketing authorizations of Esmya (ulipristal acetate) and its generics for uterine fibrosis after confirming the drug can cause serious liver injuries. Read More
Multiple drugmakers have reportedly drafted a public pledge not to seek FDA approval of their COVID-19 vaccines until they meet certain safety and efficacy standards even as President Trump said a vaccine may be ready as soon as October. Read More
The FDA’s Aug. 23 Emergency Use Authorization (EUA) for convalescent plasma to treat COVID-19 has left hospitals with a choice — give the treatment to individual patients under the EUA or enroll them in clinical trials that will help settle the question of the treatment’s safety and efficacy. Read More
Researchers from Moscow’s Gamaleya Research Institute have posted results from two phase 1/2 trials of their controversial COVID-19 vaccine, showing it was safe and induced the production of antibodies in all adult volunteers. Read More
The U.S. may be gearing up for vaccine distribution, but a World Health Organization (WHO) spokesperson said Friday that the international agency doesn’t expect to see widespread vaccination with a COVID-19 vaccine until the middle of next year, stressing that more time is needed for late-stage clinical trials. Read More