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

Irish medtech firm InVera Medical wins EU nod for breakthrough vein treatment device

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

Roche appoints Mark Dawson as new Head of Pharma Research and Early Development

Dawson joins Roche from the Peter MacCallum Cancer Centre, where he serves as Associate Director of Research

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

Dewpoint Therapeutics selects groundbreaking MYC development candidate

MYC, a master regulator of oncogenic transcription, drives multiple high-burden cancers but has long eluded direct pharmacologic control

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

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