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...
Singapore’s Health Sciences Authority (HSA) is seeking feedback on draft guidelines released on standalone medical mobile applications and qualification of clinical decision support software (CDSS). Based on the International Medical Device Regulators Forum’s (IMDRF)...
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...
Health Canada has granted BeiGene approval for BRUKINSA (Zanubrutinib) to treat mantle cell lymphoma (MCL) in adults who have already received at least one other prior treatment. As global, science-driven biotechnology company, BeiGene focuses on improving treatment...
AstraZeneca has been granted FDA approval for its once-weekly diabetes medicine Bydureon (exenatide) to treat children (aged 10-18) with type-2 diabetes. The drug, an injectable suspension, aims to lower blood sugar rates. The approval is based on a late-stage study...
Our LATAM series continues this week with Mexico’s medical device regulatory pathway. In 2019, Mexico’s import medical device market was estimated to be approximately $5.7 billion USD. In 2020, that number increased to $6.5 billion USD. With demand for medical devices...
Merck (also known as MSD outside of North America) and Eisai Inc. announced that the FDA (Food and Drug Administration) has given approval for the combined treatment of Merck’s KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, and Elsai’s LENVIMA (lenvatinib), a...
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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