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FDA's DMF Prior Assessment Process Opens Early Review Window for API Suppliers
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Dupixent Clears FDA for CSU in Children as Young as Two

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FDA's DMF Prior Assessment Process Opens Early Review Window for API Suppliers

FDA's GDUFA III prior assessment process lets Type II API DMF holders request review six months before ANDA submission to reduce approval delays.

Pharma Now Editorial Team

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Dupixent Clears FDA for CSU in Children as Young as Two

FDA approves Dupixent for CSU in children aged 2-11, using efficacy extrapolation and PK bridging -- a regulatory model with broad pediatric biologic implications.

Pharma Now Editorial Team

Pharma Now

Inventiva Builds Commercial Infrastructure Ahead of MASH Phase 3 Readout

Inventiva appoints CFO, CLO, and CPO ahead of NATiV3 Phase 3 lanifibranor data expected Q4 2026.

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Fixed-Dose Triple Combination Cuts Recurrent Stroke Risk by 39%

TRIDENT trial data show GMRx2 cut recurrent stroke risk by 39% in ICH survivors over three years, published in NEJM.

Pharma Now Editorial Team

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