The approval covers a first-line maintenance treatment for an aggressive form of small cell lung cancer, a historically difficult-to-treat disease.
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The regulator's green light for Rhapsido, a first-in-class oral treatment for chronic hives, positions the company to challenge injectable rivals.
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Gene therapy candidate TSHA-102 for Rett syndrome receives key designation, paving the way for an accelerated regulatory pathway.
The company outlined key milestones for its sublingual drug delivery platform, including a planned 2025 FDA submission for its high-dose aspirin.
Zepzelca combo becomes first approved maintenance treatment for extensive-stage small cell lung cancer, a historically difficult-to-treat disease.