Regulatory and Compliance Updates news

1 September 2026

GSK advances mRNA seasonal flu vaccine to phase III

Phase II showed higher immune responses vs licensed comparators and acceptable safety; phase III starts Sept 2026 with Fast Track FDA status.
31 August 2026

Veloxis doses first patient in Phase 2 RENGEVITY-201 of pegrizeprument (VEL-101)

Phase 2 trial compares pegrizeprument with tacrolimus in up to 120 de novo kidney transplant recipients; primary endpoints are safety, pharmacokinetics and pharmacodynamics.
31 August 2026

Amgen: Repatha reduces all‑cause mortality in high‑risk primary prevention (VESALIUS‑CV)

Pre‑specified VESALIUS‑CV analysis shows evolocumab plus background therapy lowers deaths and major CV events in high‑risk adults without prior MI/stroke.
28 August 2026

Takeda: FDA approves MIMRYLO (rusfertide) for erythrocytosis in polycythemia vera

First-in-class hepcidin mimetic approved for adult PV erythrocytosis; Phase 3 VERIFY showed hematocrit control, reduced phlebotomy and improved fatigue.
28 August 2026

Eli Lilly’s Mounjaro approved by FDA to reduce cardiovascular risk in adults with type 2 diabetes

First GIP+GLP‑1 agonist authorised to lower major adverse cardiovascular events in high‑risk adults with type 2 diabetes; SURPASS‑CVOT enrolled >13,000 with ~4‑year median follow‑up.
25 August 2026

Olin and Huntsman shareholders approve all‑stock merger to form OlinHuntsman

Transaction cleared overwhelming preliminary shareholder votes; remains subject to regulatory approvals, certification and other customary closing conditions with closing targeted H1 2027.

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