26 February 2024
26 February 2024
Following major successes in the RSV landscape over the last few years, regulators debate rollout plans.
Teva will exclusively market the biosimilar in the US, leveraging its sales and marketing infrastructure.
The positive opinion is based on findings from the Phase III COMMANDS trial, which met its primary endpoint.
The approval is based on data from the Phase III KEYNOTE-671 trial.
The FDA's Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.
Total revenue dropped to $6.8bn primarily due to a decline in sales of the company’s Covid-19 vaccine, Spikevax.
Sanofi and Regeneron’s Dupixent has received priority review by the US FDA, with a target action date of 27 June.
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