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The PMA application seeks approval for tumor treating fields (TTFields), in combination with temozolomide chemotherapy, as a first-line treatment for glioblastoma (GBM). The submission of PMA is based

With the acquisition, Juno will now have access to transformative cell selection and activation capabilities, advanced manufacturing automation, improved supply chain and lower expected cost of goods. According

Amitiza is a chloride channel activator that acts locally in the small intestine to restore motility and to address the underlying pathophysiology and secondary symptoms of constipation. Under

Objective of the project is to use power of the body’s own immune system to attack cancer cells and discover possible new treatment options for cancer patients. By

An upfront payment of $87.5m has been made by Pfizer for the minority equity interest and exclusive option. As part of the deal, Pfizer will make additional potential

The agency has acknowledged receipt of the application and will notify the company when the review process is completed. If the FDA grants orphan drug designation, Trevyent would

The deal will focus on the development of basic research including studies on pathogenesis and drug susceptibility of cancer by promoting exchanges among researchers, physicians, and others engaged

The agency lifted the clinical hold after reviewing additional information related to the product candidates’ delivery devices. The company said that the US clinical development of these product

The one-month, prospective, multicentre, open-label Phase II trial enrolled a total of 39 pediatric patients in the US and is designed to characterize safety, procedural factors and clinical