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AstraZeneca (AZ) responded to National Institutes of Health (NIH) concerns over its interim vaccine trial data by releasing its primary analysis results yesterday, but the embattled company’s two-dose shot faces intense scrutiny, with the European Medicines Agency (EMA) holding an expert meeting on March 29 to review possible links to blood clots. Read More
The University of California, San Francisco and Johns Hopkins University have launched an online archive of documents associated with the numerous lawsuits filed against drugmakers alleged to have fueled the U.S. opioid epidemic. Read More
The European Medicines Agency (EMA) has concluded its evaluation of a small number of blood-clot cases in patients vaccinated with AstraZeneca’s (AZ) COVID-19 vaccine, finding the two-shot inoculation is still safe and effective, though it could be associated with low levels of blood platelets in very rare instances. Read More
A number of EU countries have temporarily put AstraZeneca (AZ) vaccinations on hold after some patients given the shot formed blood clots, but the European Medicines Agency (EMA) said it has no reason to believe the vaccine is responsible. Read More
A Pfizer plant that will produce the company’s COVID-19 vaccine has been observed by FDA investigators as having quality control lapses, but Pfizer says the problems will be resolved before the facility supplies any COVID-19 vaccine doses. Read More
CorMedix has received a Complete Response Letter (CRL) from the FDA regarding a New Drug Application (NDA) for its catheter-lock solution, DefenCath (taurolidine/heparin). Read More
From March to October 2020, during the height of the COVID-19 pandemic, the FDA conducted just 52 domestic on-site pharmaceutical inspections and all but halted foreign inspections ― moves that have worried some regulatory experts. Read More