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Less than a week after the FDA halted Juno Therapeutics’ Phase 2 cancer trial over three patient deaths, the agency has given the company the go-ahead to resume the trial. Read More
Less than a week after the FDA halted Juno Therapeutics’ Phase 2 cancer trial over three patient deaths, the agency has given the company the go-ahead to resume the trial. Read More
The FDA and the European Medicines Agency have formed a new working group focusing on incorporating patient perspectives into drug development, evaluation and post-marketing activities. Read More
China has released details of a pilot program that extends drug product licensing to domestic research and development institutions and their personnel. Read More
Even with an abundance of FDA work left undone with biosimilars, industry development activities seem unaffected, with many “extremely active” in that space, an agency official says. Read More