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European regulators want drugmakers to develop pharmacovigilance plans that include tracking pharmacogenomic data to assess drug safety risks that may apply only to small patient populations. Read More
Sponsors of vaccine trials intended to support a marketing submission in China have seven days to report study-related fatalities and another eight days to file follow up reports, according to a new China Food and Drug Administration guideline. Read More
Pfizer’s lung cancer drug dacomitinib has failed in two Phase III clinical trials and analysts aren’t holding out much hope for results from a third Phase III study expected next year. Read More
A new Tufts University report praises the FDA’s breakthrough therapy program for its potential to advance new drugs and biologics targeting unmet needs. Read More
FDA reviewers have unveiled the top five reasons for drug approval delays and denials over a twelve-year period, noting that many could be avoided if drugmakers submitted more accurate and useful information. Read More