NEW YORK (AP) -- Shares of Chelsea Therapeutics International Ltd. More thandoubled in value Wednesday after the company said the Food and Drug Administration took a more favorable view of a recent ...
The company is looking to get Northera approved for the treatment of symptomatic neurogenic orthostatic hypotension (:NOH) in patients with primary autonomic failure (Parkinson's disease, multiple ...
A January advisory panel meeting and potential FDA approval in February could move the needle for this small biotech. Investors betting Chelsea (NASDAQ: CHTP) would win FDA approval for its drug ...
The approval was granted under the FDA’s accelerated approval program, which allows conditional approval of a drug for an unmet medical condition, provided additional studies are conducted. However, ...
Shares in Chelsea Therapeutics (CHTP) skyrocketed Wednesday after the FDA surprised some market watchers by approving the company’s lead drug candidate, Northera, for treatment of neurogenic ...
Chelsea Therapeutics (NASDAQ:CHTP) CEO Simon Pedder’s recent defense of drug candidate Northera omitted a key detail: The U.S. Food and Drug Administration reviewer for Northera recommended the agency ...
After the markets closed on Wednesday, Chelsea Therapeutics ($CHTP) put out the word that the FDA had rejected Northera, a troubled program that drew regulatory ...
Chelsea Therapeutics (NASDAQ:CHTP), regrouping from orphan drug Northera’s failure to secure regulatory approval, now plans to resubmit a new drug application in early 2013 with data from a modified ...
(HealthDay)—Northera (droxidopa) has been approved by the U.S. Food and Drug Administration to treat a rare, chronic condition characterized by a sudden drop in blood pressure when a person stands.
Orphan disease or not, chances don't look good. The third Food and Drug Administration decision in three days is scheduled for tomorrow, when the agency is scheduled to decide on the fate of Chelsea ...
Investors betting Chelsea would win FDA approval for its drug Northera for neurogenic orthostatic hypotension, or NOH, in multiple systems atrophy and Parkinson's patients, were dealt a disappointing ...