(PRESS RELEASE) PARIS, 20-Jul-2021 — /EuropaWire/ — Sanofi (EPA: SAN), a global biopharmaceutical company focused on human health, has announced fexinidazole approval by the US Food and Drug Administration (FDA) as the first all-oral treatment for both stages of the … Read the full press release
Posted in France, Healthcare, News, Pharma & Biotech
Tagged Central African Republic, Democratic Republic of Congo, DNDi, Dr Bernard Pécoul, Drugs for Neglected Diseases initiative, FDA, fexinidazole, HAT, Human African trypanosomiasis, Luc Kuykens, National Sleeping Sickness Programs, neuropsychiatric symptoms, parasitic disease, Sanofi, sleeping sickness, Trypanosoma brucei gambiense, tse-tse fly, US Food and Drug Administration, WHO, World Health Organization
29-8-2013 — /EuropaWire/ — The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications. Quality-by-design is a science- and … Read the full press release
Posted in European Union, Government, Healthcare, Pharma & Biotech, Science
Tagged EMA, European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency, parallel assessment of quality-by-design applications, pharmaceutical industry, science- and risk-based approach, US FDA, US Food and Drug Administration
Companies secure certified compatibility of Hansen Medical’s Magellan® Robotic System and Philips’ Allura interventional X-ray systems Magellan System is currently the only robotic system on the market intended for use in the peripheral vasculature Mountain View, CA, Andover, MA, 01-8-2013 … Read the full press release
Posted in Business, Electronics & Machinery, Healthcare, Netherlands, Technology
Tagged 510(k) clearance, Allura interventional X-ray systems, Bert van Meurs, Bruce Barclay, CE marking, certified compatibility, Hansen Medical, Intravascular robotics, Magellan Robotic System, peripheral vasculature, robotic catheter technology, Royal Philips, US Food and Drug Administration
Recognition by the US Food and Drug Administration (FDA) that RLX030 has the potential to address a serious unmet medical need If approved, RLX030 has the potential to be the first treatment breakthrough for Acute Heart Failure patients in 20 … Read the full press release
Posted in Government, Healthcare, Pharma & Biotech, Science, Switzerland
Tagged acute heart failure, AHF, Basel, David Epstein, FDA, Novartis, RLX030, serelaxin, US Food and Drug Administration
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