TSO3 Inc, announced that the U.S. Food and Drug Administration has cleared TSO3’s expanded indications for use (IFU’s) of its STERIZONE® VP4 Sterilizer.“Our extended IFU claims have been cleared by the FDA demonstrating the truly superior capabilities of our STERIZONE® Sterilization System,” said TSO3 President and CEO, R.M. (Ric) Rumble.
U.S. Food and Drug Administration has approved the Abbott's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the United States.
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Five Prime Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to FPA144 for the treatment of gastric cancer, including cancer of the gastroesophageal junction in patients whose tumors overexpress FGFR2b. FPA144 is an anti-FGF receptor 2b (FGFR2b) humanized monoclonal antibody in clinical development as a targeted immune therapy.
Insys Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, SyndrosTM, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC"). Syndros is approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Syndros is currently awaiting scheduling by the U.S. Drug Enforcement Administration.
Onxeo S.A., an innovative company specialized in the development of orphan oncology therapies, announced it received a Notice of Allowance from the US Patent and Trademark Office (USPTO) relating to a key patent for its signal interfering DNA product candidate, AsiDNA.
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