This article was originally published in The Gray Sheet
Premarket approval application for the company's scanning laser platform is accepted for filing by FDA. The PMA "contains data from multiple investigators at various [U.S.] sites" and will not require panel review, the firm says...
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The company will use the proceeds to fund clinical trials, expand commercialization of its targeted radiation therapy, and file for CE marking in Europe.
Advanced Medical Solutions said it will buy Raleigh Adhesive Coatings for £22m ($29m) in cash to strengthen its overall wound care business.
While Amgen said the Phase III GALACTIC-HF results for omecamtiv mecarbil did not meet its high expectations for the heart failure candidate, Cytokinetics sees a path to treating certain patients.