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The FDA has extended the PDUFA date of Dynavax’s investigational hepatitis B vaccine Heplisav-B by three months to review new data in the company’s resubmitted BLA. Read More
China is banning wholesalers from selling vaccines after millions of dollars’ worth of illegal products were sold to patients in that country. Read More
The European Medicines Agency is providing guidance on how drugmakers can best incorporate patient-reported outcomes in developing oncology studies. Read More
The FDA has hit Oeyama-Moto Cancer Research Foundation’s IRB for failing to define its operational protocol, leading to inadequate communication with clinical investigators and meager documentation. Read More