Dive into the archives.
- 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 [...]
- 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 [...]
- Merck KGaA Submits Application For Cladribine Tablets In US
Germany’s Merck KGaA has made further progress in its bid to be the first company to market an oral multiple sclerosis treatment by filing cladribine in the USA.
The German company’s US subsidiary EMD Serono has submitted a New Drug Application with the Food and Drug Administration for cladribine as a therapy for reducing relapses in [...]
- Biogen Receives FDA Warning for Tysabri (re Internet Ads)
FDA Warns Drug Firms Over Internet Ads
WASHINGTON — The Food and Drug Administration warned 14 major pharmaceutical companies about brief Internet ads that accompany searches on Google and other search engines, saying the ads were misleading because they didn’t include risk information.
The warnings marked one of the first major actions by the FDA to crack [...]
- Copaxone FDA approved for First Episode (CIS, for you seasoned readers)
COPAXONE(R) Approved By The FDA For Patients With A First Clinical Event Suggestive Of Multiple Sclerosis
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for COPAXONE® (glatiramer acetate injection) to include the treatment of patients who have experienced a first clinical episode and [...]
