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The FDA has released its annual report to Congress on statistics on delays in approval of applications related to citizen petitions and petitions for stays of agency actions for the 2015 fiscal year. Read More
The UK’s drug pricing watchdog has recommended that the National Health Service reimburse Pfizer lung cancer drug Xalkori, while recommending against refunds for Novartis’ breast cancer therapy Everolimus and Janssen’s non-Hodgkin’s lymphoma drug Imbruvica. Read More
After the FDA tackled compliance with international standards for restricting elemental impurities in finished drugs, the EMA has issued guidance on the same topic. Read More
Less than a day after finalizing its acquisition of Allergan’s generics division, Israeli drugmaker Teva Pharmaceutical disclosed plans to pick up the company’s distribution arm for $500 million. Read More
The Chinese FDA has made sweeping reforms to the country’s nine-year-old drug registration rules, looking for industry feedback on a range of drug approval related revisions. Read More