For patients suffering from either of the predominant variations of ANCA-associated vasculitis, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has...
Bioproject has received approval from the European Medicines Agency (EMA) for their Ozawade (pitolisant) to treat adult excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA). The approval is based on two Phase III clinical studies to study...
The US FDA (Food & Drug Administration) and the EMA (European Medicines Agency) have launched a joint pilot designed to give parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines (as they’re referred to in the EU). The aim of...
It has been almost four years since the European Commission passed the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 on May 26, 2017. With the new regulation set to be implemented in 2022, medical device manufacturers looking to market their products...
Over the last several years, patient-centricity has been a key theme in the healthcare sphere for improving drug therapies and medical devices for patients all around the world. To better serve patients, life science companies are putting in more effort on listening...
The European Medicine’s Agency (EMA) announced today (1/29) it’s approval of the AstraZeneca and University of Oxford’s COVID-19 vaccine. The approval marks the third vaccine passed by the EMA. The vaccine is administered as two doses, with the second coming between 4...
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