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The European Medicines Agency (EMA) said it is giving a fast-track review to a conditional marketing authorization request from Gilead Sciences for using remdesivir to treat COVID-19 patients. Read More
Regeneron Pharmaceuticals and Vir Biotechnology said they will soon begin clinical trials of monoclonal antibodies they hope will be able to prevent or treat COVID-19 patients. Read More
The FDA yesterday released a temporary final guidance allowing drug companies to ship samples directly to a patient’s home during the pandemic, as long as their practitioner has given permission. Read More
The FDA has launched a pilot program with the National Telecommunications and Information Administration (NTIA) to curb illegal opioid sales online. Read More
Oxford Biomedica has signed a five-year collaboration agreement with the Vaccines Manufacturing and Innovation Center (VMIC) to manufacture viral vector-based vaccines. Read More
Results from preliminary research show that AstraZeneca’s blood cancer treatment Calquence (acalabrutinib) provides a benefit in hospitalized COVID-19 patients. Read More
The UK’s Drug Safety Research Unit (DSRU), a nonprofit that studies the safety of medicines, has published the first benefit-risk analysis for Gilead Sciences’ antiviral remdesivir, finding that it has a favorable overall profile, although questions remain about the drug’s safety. Read More