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Recent Posts

Regulatory Insights from EMA CHMP Meeting Highlights
The EMA CHMP Meeting Highlights from 22-25 June 2026 show the committee advancing six new medicines while maintaining rigorous evidentiary standards for complex and rare conditions. Positive opinions covered an inactivated influenza vaccine for adults 50 and older, a levodopa-carbidopa intestinal...

KEYTRUDA Combination Therapy Gains FDA Approval for Advanced Triple-Negative Breast Cancer
The FDA has approved KEYTRUDA combination therapy with Trodelvy as first-line treatment for adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 at a Combined Positive Score of 10 or greater. This marks the first regulatory nod for a PD-...

Innovations in Calcified Carotid Lesion Preparation for Enhanced Stroke Management
Johnson & Johnson has begun enrolling patients in the SKYWARD clinical program, advancing calcified carotid lesion preparation with a purpose-built intravascular lithotripsy platform that fractures hardened plaque to improve stent deployment. This first-of-its-kind