There may not be a worse time to push a new drug through FDA-especially a "me-too" product with a questionable benefit-risk profile. Until Congress releases its grasp on the approval process, FDA isn't taking any chances. Unfortunately for industry, a few drugs are getting caught in the crossfire. Merck seemed unprepared for the new climate with Arcoxia; will other sponsors learn the lesson?
By Kate Rawson
The rejection of Merck & Co. Inc. ’s etoricoxib (Arcoxia) by the Food & Drug Administration should send a very...
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Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
