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...

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-...

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

Cemdisiran gMG treatment has cleared a critical hurdle after the FDA and EMA accepted Regeneron’s regulatory submissions for review in anti-AChR antibody-positive generalized myasthenia gravis (gMG). The investigational siRNA therapy targeting complement protein C5 could become the first subcutan...

The Trodelvy ADC approval by the European Commission delivers the first antibody-drug conjugate approved for first-line use in adults with unresectable or metastatic triple-negative breast cancer who are ineligible for PD-1 or PD-L1 inhibitors. This

Cemiplimab Cervical Cancer Access has been endorsed by NICE for adults with recurrent or metastatic cervical cancer that has progressed after platinum-based chemotherapy, provided patients have not previously received immunotherapy. The final draft guidance confirms that this PD-1 inhibitor deliv...