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Indian authorities want clinical trial sites accredited and more heavily regulated. In a new report, a panel of advisors to the Ministry of Health and Family Welfare spells out specific reforms aimed at addressing past weaknesses in the country’s clinical investigation and drug approval processes. Read More
The European Commission has approved Roche’s Kadcyla to treat patients with HER2-positive locally advanced or metastatic breast cancer previously treated with Herceptin and/or a taxane. Read More
The European Commission has granted marketing approval for Bayer and Algeta's Xofigo to treat castration-resistant prostate cancer (CRPC) that has spread to bones but not other organs. Read More
The European Medicines Agency (EMA) has provided generic drugmakers its first roadmap to meeting standardized EU bioequivalence requirements. Read More
A panel of FDA advisors Nov. 14 overwhelmingly voted against approval of Sanofi’s Lemtrada for an expanded indication to treat relapsing multiple sclerosis (MS). Read More
FDA advisers overwhelmingly voted Nov. 14 to recommend approval of Vanda’s sleep drug tasimelteon for the visually impaired despite some concern over a clinical trial’s primary endpoint. Read More
The FDA says someone hacked into CBER’s online submission system last month and may have put users in danger of having their online personal identity stolen. Read More
The FDA is expected to approve 34 new drugs this year, down from a record 43 approved in 2012. That drop is expected to be temporary, though, as more drugmakers adjust their pipelines to take advantage of the agency’s breakthrough therapy pathway. Read More
The Department of Justice is investigating a Phase III study of AstraZeneca’s (AZ) heart drug Brilinta, which analysts and experts say could revolve around allegations of data falsification. Read More
Senior European Medicines Agency (EMA) officials are cautioning their peers that when it comes to making regulatory decisions, high levels of risk aversion may do more harm than good. Read More
FDA advisers overwhelmingly voted Thursday to recommend approval of Vanda’s sleep drug tasimelteon for the visually impaired despite some concern over a clinical trial’s primary endpoint. Read More