Idec agrees to market lymphoma radioimmunotherapy Zevalin (ibritumomab) in two kits - an imaging kit with indium and a therapeutic kit with yttrium - as requested in FDA "complete review" letter. Idec will also submit analyses of hospitalization and cytopenia seen in clinical trials, as well as manufacturing information. The company will respond to FDA in mid-July, Idec says. The BLA had a user fee action date of May 3
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
