US Food and Drug Administration

Drugs for Neglected Diseases initiative: first all-oral treatment for Human African trypanosomiasis (sleeping sickness) gets US Food and Drug Administration (FDA) approval

(PRESS RELEASE) PARIS, 20-Jul-2021 — /EuropaWire/ — Sanofi (EPA: SAN), a global biopharmaceutical company focused on human health, has announced…

3 years ago

EMA and US FDA published joint first conclusions of parallel assessment of quality-by-design applications (QbD)

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…

11 years ago

US FDA granted breakthrough therapy designation to Novartis’s BYM338 for sporadic inclusion body myositis

Designation highlights potential of BYM338 to address an unmet medical need in a serious disease If approved, BYM338 has the…

11 years ago

Hansen Medical’s Magellan Robotic System and Philips’ Allura interventional X-ray systems reached certified compatibility

Companies secure certified compatibility of Hansen Medical’s Magellan® Robotic System and Philips’ Allura interventional X-ray systems Magellan System is currently…

11 years ago

Novartis announced US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to its serelaxin (RLX030) for acute heart failure

Recognition by the US Food and Drug Administration (FDA) that RLX030 has the potential to address a serious unmet medical…

11 years ago