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FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
Biopharma | December 16, 2025

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease


Zenas BioPharma and InnoCare hit key milestone in Lupus drug trial, secures China Phase 3 nod
Clinical Trials | December 16, 2025

Zenas BioPharma and InnoCare hit key milestone in Lupus drug trial, secures China Phase 3 nod

The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort


Alphyn Biologics bags $25 million financing to advance breakthrough skin disease therapies
News | December 16, 2025

Alphyn Biologics bags $25 million financing to advance breakthrough skin disease therapies

Alphyn is developing Zabalafin Hydrogel as the first therapy to simultaneously tackle the interconnected drivers of AD


Caplin Point Laboratories’ injectables facility completes INVIMA audit successfully
Drug Approval | December 15, 2025

Caplin Point Laboratories’ injectables facility completes INVIMA audit successfully

This is also an important milestone in our product strategy for our expansion into the larger Latin American market


Eiko LifeSciences to acquire 51% stake in SSM Formulations
News | December 15, 2025

Eiko LifeSciences to acquire 51% stake in SSM Formulations

The plant can reach an annual capacity of 300 crore tablets and 90 crore capsules


FDA completes inspection of SMS Pharma’s Vizag facility
Drug Approval | December 14, 2025

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483