Pharma overhaul: EMA hails “Once-in-a-Generation” reform

The reform is set to modernise how medicines are developed, authorised, and made available across the EU

Sanofi flags delay in FDA review of Tolebrutinib for progressive multiple sclerosis

Neuren partner Acadia bags FDA go-ahead for new DAYBUE STIX powder for Rett Syndrome

The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste

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

Anova launches AI-powered patient matching platform to speed clinical trial enrollment

Clinical trial enrollment has long been a bottleneck in drug development

Eiko LifeSciences to acquire 51% stake in SSM Formulations

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

Anil Koul joins Mankind Pharma as Group Chief Scientific Officer

More than five drug candidates from his team progressed to human trials including drugs like Rilematovir (Phase IIb), and Bedaquiline

Biocon Biologics strikes deal to sell its version of the eye drug Aflibercept worldwide

All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

Merck wins key EU backing to expand use of PAH Drug WINREVAIR

WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states