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AbbVie Gains FDA Approval for Decnupaz in Ultra-Rare Hematologic Malignancy BPDCN
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Zentalis Appoints Shannon Campbell and Sarah Kelly to Build Commercial Infrastructure for Azenosertib Launch

Pharma Now Editorial Team

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AbbVie Gains FDA Approval for Decnupaz in Ultra-Rare Hematologic Malignancy BPDCN

AbbVie's Decnupaz gains FDA approval for BPDCN, raising GMP and CMC compliance priorities for ADC manufacturers and QA teams.

Pharma Now Editorial Team

Pharma Now

Zentalis Appoints Shannon Campbell and Sarah Kelly to Build Commercial Infrastructure for Azenosertib Launch

Zentalis adds Shannon Campbell to its board and Sarah Kelly as SVP of Commercial Strategy as azenosertib advances through registrational trials.

Pharma Now Editorial Team

Pharma Now

Dyne Therapeutics Submits BLA for Z-Rostudirsen After DELIVER Trial Meets Dystrophin Endpoints

Dyne Therapeutics files a BLA for z-rostudirsen under accelerated approval, while Sartorius opens a €140M CGT manufacturing center in Germany.

Pharma Now Editorial Team

Pharma Now

FDA Finalizes ICH M7(R2) Guidance on Mutagenic Impurity Assessment and Acceptable Intake Calculations

FDA finalizes ICH M7(R2) guidance on mutagenic impurity control, updating acceptable intake calculations and harmonizing global assessment standards.

Pharma Now Editorial Team

Pharma Now