Tranzyme Pharma has reported that its potent and selective ghrelin agonist, TZP-101, demonstrated effectiveness in the treatment of gastroparesis, an inability of the stomach to empty food efficiently,
The Sapphire study will be carried out in Europe, America and Asia. Approximately 70 hospital centers will participate. The Phase III study is designed as a randomized, active-controlled,
Ethicon Endo-Surgery, a Johnson & Johnson company, has received the FDA’s approval for the company’s investigational device exemption application to conduct the study of devices designed for use
Eli Lilly and Company has reported that the US District Court for the Southern District of Indiana has issued a preliminary injunction to prevent the launch of a
Abiomed, a provider of heart support technologies, has received 510(k) clearance from the FDA for its Impella 5.0 and Impella LD circulatory support devices. This 510(k) clearance designates
BioMS Medical has reported that the independent data safety monitoring board for the company’s pivotal Phase III Maestro-01 Canadian/European trial of dirucotide in patients with secondary progressive multiple
Esperance Pharmaceuticals has reported positive results from the company’s preclinical program that support the initiation of clinical trials in cancer. EP-100 is the first candidate from the company’s
The PSA test, as well as how it is used to guide patient care (e.g., at what age men should begin regular testing, intervals at which the test
Topica Pharmaceuticals has initiated patient enrollment in a Phase II clinical trial evaluating luliconazole for the treatment of tinea pedis. The Phase II, multi-center, randomized, double-blind trial is
The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses
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