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  • Simantini Singh Deo

Takeda Gains FDA Supplemental Approval for HYQVIA in CIDP Maintenance Therapy June 2026
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Roche Gains FDA Approval for First PTEN-Loss Companion Diagnostic in Prostate Cancer

Simantini Singh Deo

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Takeda Gains FDA Supplemental Approval for HYQVIA in CIDP Maintenance Therapy June 2026

FDA issues fourth supplemental approval for Takeda's HYQVIA, adding CIDP maintenance therapy to its labeled indications as of June 11, 2026.

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Roche Gains FDA Approval for First PTEN-Loss Companion Diagnostic in Prostate Cancer

Roche's FDA approval of the first PTEN-loss companion diagnostic sets a new co-development and labeling benchmark for prostate cancer drug-diagnostic programmes.

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Lilly's Jaypirca Achieves 45% Progression Risk Reduction in Phase 3 CLL Trial

Lilly's Jaypirca cuts progression risk by 45% in Phase 3 CLL trial, signaling label expansion with manufacturing scale-up implications.

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Alithea Genomics Signs Deal with Revvity to Scale Transcriptomic Profiling in Drug Discovery

Alithea Genomics and Revvity integrate MERCURIUS DRUG-seq into a global screening portfolio to scale transcriptomic profiling in early drug discovery.

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