FDA grants approval for Novavax, Inc.'s lead candidate
The FDA approval covers an expanded adult population, based on pivotal trial data submitted in the company's application. NVAX plans a commercial launch and has flagged peak sales estimates in upcoming investor materials.
FDA grants approval for Regeneron Pharmaceuticals's next-generation formulation
The FDA approval covers an expanded adult population, based on pivotal trial data submitted in the company's application. REGN plans a commercial launch and has flagged peak sales estimates in upcoming investor materials.
VRTX Phase 1 trial showed a statistically significant improvement
Vertex Pharmaceuticals reported topline data from its Phase 1 study. The company said it will present full results at an upcoming medical conference and discuss next regulatory steps with the FDA.
The FDA approval covers an expanded adult population, based on pivotal trial data submitted in the company's application. NVAX plans a commercial launch and has flagged peak sales estimates in upcoming investor materials.
The FDA approval covers an expanded adult population, based on pivotal trial data submitted in the company's application. REGN plans a commercial launch and has flagged peak sales estimates in upcoming investor materials.
Vertex Pharmaceuticals reported topline data from its Phase 1 study. The company said it will present full results at an upcoming medical conference and discuss next regulatory steps with the FDA.