The FDA needs more details from Amgen Inc. about its postmarketing safety surveillance study program before regulators will approve Prolia (denosumab) as a treatment for postmenopausal osteoporosis, the company said Monday. (BioWorld Today)

COLLEGE PARK, Md. — An FDA panel Wednesday voted 12 to 1 that Acorda Therapeutics Inc.'s Phase III trials provided substantial evidence that fampridine sustained-release was effective in improving the walking ability in patients with multiple sclerosis. (BioWorld Today)

Acorda Therapeutics Inc.'s stock plunged 21.4 percent after FDA drug reviewers raised concerns in briefing documents about the efficacy of Amaya (fampridine sustained-release) in improving the walking ability in patients with multiple sclerosis. (BioWorld Today)