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The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a new drug

A grant of orphan drug status provides seven years of market exclusivity for the orphan indication after approval by the FDA, as well as tax incentives, study design

AcryMed will manufacture for I-Flow a new line of silver transparent wound-site dressings, which I-Flow expects to bring to market in the first half of this year. In

Earl Yager, Chad’s president and CEO, said, “With additional proprietary products in an advanced stage of development and a roadmap of additional product development opportunities based on our

Orphan drug status was granted for the treatment of both anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or

The EOquin registration plan calls for two double blind, placebo-controlled, randomized Phase III clinical studies, each with 562 patients with Ta G1 or G2 low risk non-invasive bladder

The MAA submission is based upon data from several trials, including the landmark TRITON-TIMI 38 clinical trial, which evaluated the safety and efficacy of prasugrel compared with clopidogrel

The total contract amount is a minimum value as Datatrak will be providing all associated services for this client’s global clinical trials utilizing Datatrak eClinical throughout the life

After IND clearance by the FDA, Hollis-Eden plans to initiate a Phase I/II dose ranging clinical trial of Apoptone in prostate cancer patients during the second quarter of