Regulatory Roundup: FDA reviewing GSK, Takeda applications for earlier lines of cancer treatment; plus Novartis, Halozyme-Genentech, MacroGenics, CSL, Lilly

FDA is reviewing four earlier or additional indications for a slate of cancer drugs, plus a first-time application for MacroGenics’ anti-HER2 mAb. The agency also approved the first quadrivalent flu vaccine and a CV application for a diabetes therapy.

Via the Real-Time Oncology Review pilot program, FDA is reviewing

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