Novartis’ Vanrafia shows promise in slowing kidney decline in IgA nephropathy

Vanrafia, a potent endothelin A receptor antagonist, received accelerated approval in the US and China in 2025 for reducing proteinuria in adults with IgAN

HanchorBio scores first FDA orphan drug tag for gastric cancer therapy

The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients

Beyfortus cuts RSV hospitalizations across two seasons in landmark study

The NIRSE-GAL study, conducted in Galicia, Spain, is the first real-world, population-based investigation of a universal RSV immunization program spanning two consecutive seasons

Teva and Sanofi duvakitug Phase 2b data show sustained efficacy in IBD

Duvakitug was well tolerated and safety was consistent with the induction study

Moderna’s new Covid vaccine mNEXSPIKE wins European approval

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe

FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma

Iberdomide has the potential to be the first approved CELMoD agent

Amgen scores EU nod for UPLIZNA in rare autoimmune disease

The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses

Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough

If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US

STADA & Bio-Thera bag European nod for Gotenfia

Clinigen bags Japan's nod to human milk-based medicine for preterm infants

PreemieFort Enteral Solution's approval marks the first time a nutritional product derived from human milk has been recognized as a prescription medicine anywhere in the world