FDA's NDA And BLA Approvals: Zypitamag, Nerlynx, Vosevi, Lusduna
Original new drugs and biologics recently approved by US FDA.
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The Merck and Samsung Bioepis formulation of Sanofi's insulin glargine was tentatively approved by FDA, a designation that permits the drug to enter the market pending the resolution of ongoing patent litigation.
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.