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Novartis begins Zolgensma study after FDA’s hold lifts
Novartis begins Zolgensma study after FDA’s hold lifts

Aiming to expand the use of Zolgensma, Novartis has announced the launch of a new phase three study following the FDA’s decision to remove restrictions and partial clinical trial hold. Novartis plans to evaluate the use of Zolgensma to treat patients (aged 2-18) for...

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 approval...

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)...

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