The FDA has granted Alkermes fast-tracked designation for Nemvaleukin Alfa (nemvaleukin) to treat patients with mucosal melanoma, following nemvaleukin’s orphan drug designation earlier in the year. Nemvaleukin alfa is Alkermes’ first investigational engineered...
The European Commmision (EC) has granted Bristol Myers approval for Opdivo (nivolumab) to treat adult esophageal or gastroesophageal junction (GEJ) cancer who have pathologic disease after previous neoadjuvant chemoradiotherapy (CRT). With the approval based on the...
Expanding on their emergency authorization from November, the FDA has granted Eli Lilly approval for the use of their COVID-19 drug baricitinib to be taken on its own and not in combination with Gilead’s drug remdesivir for patients with COVID-19. With the...
LifeSignals’ LX1550 Multiparameter Remote Monitoring Platform has been granted FDA Class II 510 (K) approval, following recent CE marketing. With the Remote Monitoring Platform, healthtech companies can improve their product and service portfolios and provide...
The FDA (Food and Drug Administration) has given Octapharma USA approval for the first-ever intravenous immunoglobulin, called Octagam 10%, to treat adult dermatomyositis. 10 out of every million people in the US live with Dermatomyositis, a rare, idiopathic...
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