Biogen Idec’s Reports Of Tysabri Side Effects Don’t Rattle FDA
Wall Street reacted sharply to disclosure of two new PML cases associated with Tysabri, but it doesn’t sound like FDA plans a regulatory response.
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FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
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US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
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A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.