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Gilead | November 21, 2020
Gilead Sciences’ Veklury, better known as remdesivir, is so far the only COVID-19 therapy officially approved by the FDA, but the World Health Organization has some other ideas about the drug’s worth. At clear odds with the FDA’s approval, the WHO has for now recommended against the use of remdesivir in any hospitalized patients—regardless of disease severity—after an expert panel said it had found no evidence that remdesivir has any meaningful effect...
Business Insights
Commonwealth Informatics, a Genpact company | January 25, 2022
Commonwealth Informatics, an independently-operated subsidiary of Genpact, and leading technology and services company with industry expertise in medical product safety and public health surveillance, today announced that it has expanded its relationship with the Medicines and Healthcare products Regulatory Agency, a medical regulatory body for the United Kingdom. MHRA has selected Commonwealth Informatics' state-of-the-art signal detection and signal management solution, Comm...
Practice Management
Citius Pharmaceutical | December 10, 2020
Citius Pharmaceuticals, Inc. ("Citius" or the "Organization") (Nasdaq: CTXR), a strength drug organization zeroed in on creating and commercializing basic consideration drug items, declared its receipt of a composed reaction and direction from the U.S. Food and Drug Administration (FDA) Division of Anti-Infective Products to the Company's Pre-Investigational New Drug (Pre-IND) meeting demand for its Mino-Wrap preparation bundle. Through its worldwide permit concurrence wi...
Pharma Tech
JelikaLite Corp | January 07, 2022
JelikaLite Corp, a medical technology company, announced that the U.S. Food and Drug Administration has granted the Breakthrough Device Designation to its Cognilum System for the reduction of symptoms of moderate to severe autism spectrum disorder in pediatric patients who are 2 to 6 years of age. The FDA’s Breakthrough Device Program recognizes medical devices that meet the criteria and hold the potential for more effective treatment or diagnosis of life-threatening or irre...
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