Topic: Food and Drug Administration
Arena Pharmaceuticals is insisting data released this morning don't worsen the case for its obesity drug, lorcaserin. As I said then, somewhat positive data showing that lorcaserin increases weight loss and lowers blood sugar were outweighed by the fact that in the ...
A long-awaited study testing Arena Pharmaceuticals' weight loss drug lorcaserin in diabetic patients raises new safety concerns about the medicine, lowering the odds that the Food and Drug Administration will ever approve it.. Echocardiograms were performed at baseline and at Weeks 24 ...
As expected, the FDA turned down Arena's application for approval of its lorcaserin obesity drug yesterday, asking for more human and animal data.. The good news for Arena is that the FDA is not currently demanding any new human studies that aren't ...
Arena Pharmaceuticals is insisting data released this morning don't worsen the case for its obesity drug, lorcaserin. As I said then, somewhat positive data showing that lorcaserin increases weight loss and lowers blood sugar were outweighed by the fact that in the ...
FDA - Don't Call Us, We'll Call You Several companies have seen their fortunes take a bad turn either in the clinic or from the Food and Drug Administration. BIOD) recently saw its application for a new formulation of insulin rejected due ...
Amylin Pharmaceuticals, Inc. (AMLN) Q3 2010 Earnings Call Transcript November 04, 2010 5:00 pm ET. Moving forward, we will refocus our efforts to promote the benefits of treatment with BYETTA and SYMLIN that we have established over the past five years.. Gaining ...
The U.S. Food and Drug Administration informed Biodel (BIOD) that it would not approve in its present form its application for Linjeta (recombinant human insulin) injection for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control. The ...
DexCom (DXCM) Q3 2010 Earnings Call November 04, 2010 4:30 pm ET. ]I would now like to turn the call over to Terry Gregg. DexCom recorded product revenue of approximately $10.8 million for the third quarter of 2010, compared to $4.6 million ...
ChromeMate is a chromium supplement manufactured by Natrol, that is marketed to help with weight loss. According to the manufacturer, the ChromeMate formula has higher bioavailability than other forms of chromium. ChromeMate comes in capsule form, and each pill contains 200mcg of ...
An advisory committee to the U.S. Food and Drug Administration 's (FDA) recently voted to keep Avandia (rosiglitazone maleate) on the market. The committee's action took place just after the same panel had concluded, following research studies, that Avandia increased the risk ...