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Bristol Myers Opdivo Wins The EC Approval for GEJ Cancer

Bristol Myers Opdivo Wins The EC Approval for GEJ Cancer

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...
FDA Approves Eli Lilly COVID-19 Drug Without Remdesivir

FDA Approves Eli Lilly COVID-19 Drug Without Remdesivir

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 HSA: SaMD Regulation Guidelines Feedback

Singapore HSA: SaMD Regulation Guidelines Feedback

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)...
Canada Approves BeiGene BRUKINSA for Mantle Cell Lymphoma

Canada Approves BeiGene BRUKINSA for Mantle Cell Lymphoma

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 Diabetes Drug Given FDA Approval for Children

AstraZeneca Diabetes Drug Given FDA Approval for Children

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...