FDA Accepts CyDex Pharmaceuticals' IND Application For Oncology Drug
CyDex Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company"s Investigational New Drug (IND) application for a clinical study of Captisol-Enabled® melphalan HCL (CDX-353). Melphalan is an FDA-approved low dose chemotherapy for multiple myeloma marketed under the brand name Alkeran® by GlaxoSmithKline.
Endocrinology
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Amgen Announces KRAS Safety Update To U.S. Prescribing Information For Vectibix(R) (Panitumumab)
prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. The scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release. AmgenPages: 1 [2]