The European Commission (EC) has granted approval of a supply contract with Novavax to purchase more than 200 million COVID-19 vaccines. The deal is an attempt to further diversity the EU’s vaccine strategy after betting heavily on their Pfizer and Moderna vaccine...
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...
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)...
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