In an unexpected move, the FDA has delayed its decision on returning Tysabri to the market. Elan and Biogen Idec said that they had been notified that regulators would now make a decision on or before June 28, three months after a decision had first been expected. An FDA expert committee has voted in favor of returning Tysabri and most analysts had concluded that despite earlier safety problems it was likely that regulators would give the multiple sclerosis drug a green light. The agency's latest move startled investors, sending Elan's shares down in overnight trading.
- here's the AP report for more information