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Results from previous trials have raised questions about the vaccine and how well it works. Data from a large U.S. study could help clear up the confusion.
According to Acadia, the FDA had said multiple times that there were no problems with its drug approval application. But last week, the agency surprisingly reversed course.
An unconventional strategy is behind the rise of Rocket, a New Jersey biotech whose executives boldly talk of turning into the "Genentech of gene therapy."
Find out how AI can help accelerate key processes to optimize product development and lifecycle management to improve commercial performance in this on-demand webinar.
At a public hearing in April, the agency will ask a panel of experts whether three immunotherapies should remain on the market for certain cancer types, the latest step in an industrywide review.
Four years after negative study results, the pharma withdrew the indication as the FDA's "industry-wide evaluation" of accelerated approvals progresses.
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