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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US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 

FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 

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.

EU Medical Countermeasures Strategy Promises More AMR Pull Incentives

 

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.