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FDA approves Myriad’s BRACAnalysis CDx for use with ovarian cancer drugBRACAnalysis CDx is First and Only FDA-Approved Test to Assess BRCA Status Myriad Genetics, Inc. (NASDAQ: MYGN) today announced that it has received approval from the U.S. Food and Drug Administratio2015/1/9
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CFDA Vice Minister Wu Zhen meets German Ambassador to ChinaOn December 22, 2014, Wu Zhen, Vice Minister of China Food and Drug Administration (CFDA), met with the delegation led by German Ambassador to China Michael Clauss. Both sides reviewed the cooperation2015/1/8
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FDA approves Namzaric drug for treatment of moderate to severe Alzheimer's diseaseActavis plc (NYSE: ACT) and Adamas Pharmaceuticals Inc. (NASDAQ: ADMS) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, a fixe2015/1/7
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Newron, Zambon announce re-submission of safinamide NDA to FDANewron Pharmaceuticals S.p.A. ("Newron"), a research and development company focused on novel CNS and pain therapies, and its commercial and development partner Zambon S.p.A., an international pharmac2014/12/30
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Catalent Biomanufacturing Center of Excellence, Madison, Wisconsin, United States of AmericaCatalent Pharma Solutions opened a state-of-the-art bio-manufacturing centre of excellence in Madison, Wisconsin, US, in April 2013. Following the inauguration, Catalent relocated its operations and 82014/12/30
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BMS's Opdivo obtains FDA accelerated approval to treat metastatic melanomaBristol-Myers Squibb (BMS) has obtained approval from US Food and Drug Administration (FDA) for its Opdivo (nivolumab) injection, for intravenous use. Opdivo is a human programmed death receptor-1 (P2014/12/29
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FDA approves Novo Nordisk’s weight loss injection, SaxendaNovo Nordisk today announced that the Food and Drug Administration (FDA) has approved the new drug application (NDA) for Saxenda®(liraglutide [rDNA origin] injection), the first once-daily glucago2014/12/29
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Eli Lilly and Adocia to co-develop ultra-rapid insulinEli Lilly and Company has entered a worldwide licensing collaboration with France-based Adocia to develop an ultra-rapid insulin, BioChaperone Lispro, to treat people with type 1 and type 2 diabetes.2014/12/25
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Higher doses of vancomycin linked to increased risk of kidney damage in children, shows studyResults of a small Johns Hopkins Children’s Center study show that hospitalized children given high-dose IV infusions of the antibiotic vancomycin to treat drug-resistant bacterial infections face an2014/12/25
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GSK submits sNDA for additional indication of eltrombopag to treat ITPGlaxoSmithKline (GSK) has submitted a supplemental new drug application (sNDA) to US Food and Drug Administration (FDA) for eltrombopag (Promacta). GSK are seeking additional approval to treat paedia2014/12/24