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- FDA delays ruling on Acorda’s MS drug until 1/2010
October 22, 2009 6:38 AM ET
HAWTHORNE, N.Y. (AP) – Acorda Therapeutics Inc. said Thursday the Food and Drug Administration delayed a ruling on its multiple sclerosis drug candidate Fampridine-SR by three months.
The agency was due to make a decision by Thursday, but the ruling is now due by Jan. 22, 2010.
Acorda said the FDA extended [...]
- Acorda Announces Positive Vote by FDA Advisory Committee for Fampridine-SR
Wed, Oct 14, 2009
* Committee Views Fampridine-SR as Safe, Effective and Clinically Meaningful for
Improving Walking in People with Multiple Sclerosis
* Conference Call Scheduled for Thursday, October 15 at 8:00 a.m. Eastern TimeHAWTHORNE, N.Y.–(Business Wire)–
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the U.S. Food and Drug
Administration (FDA) Peripheral and Central Nervous System Drugs (PCNSD)
Advisory Committee voted [...]
- MS Walking Improvement Drug Receives Negative FDA Review
By MATTHEW PERRONE (AP) – 2 days ago
WASHINGTON — Shares of Acorda Therapeutics plummeted Friday after the Food and Drug Administration issued a negative opinion that questioned the safety and effectiveness of the company’s multiple sclerosis drug.
A panel of FDA advisers is scheduled to meet next week to vote on Acorda’s Fampridine-SR, which is designed [...]
- Fampridine-SR Receives Priority FDA Review for Walking Drug
Acorda’s shares up sharply on news of FDA priority review for Fampridine-SR in multiple sclerosis
Mark Todoruk
Shares in Acorda Therapeutics soared as much as 28 percent after the company announced that the FDA accepted its filing of Fampridine-SR (4-aminopyridine) to treat multiple sclerosis, and granted it a priority review. Analyst Phil Nadeau of Cowen & Co. [...]
