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The FDA awarded Janssen’s esketamine a second breakthrough designation for major depressive disorder with imminent risk of suicide, adding a second potential indication for the investigational compound. Read More
The European Medicines Agency is recommending halting sales of 136 drugs whose approval came from flawed studies performed at the Semler Research Centre in India. Read More
After nearly two years, the EMA is formalizing its iterative pathway program that saw six applications progress to formal advice from the agency. Read More