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The European Commission has granted marketing authorization for ZINBRYTA™ (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), Biogen and Abbvie announced. ZINBRYTA is a once-monthly, self-administered, subcutaneous injection.
ObsEva, a Swiss biopharmaceutical company innovating women’s reproductive health and pregnancy therapeutics, announced that its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OBE2109 has been cleared and the company is authorized to begin enrolling patients in the Phase 2b clinical study (EDELWEISS) with OBE2109 for the treatment of endometriosis.
Sanofi, a global healthcare leader, and its vaccines global business unit Sanofi Pasteur announced a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development of a Zika vaccine candidate.
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.
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.
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