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

EU to withdraw Levamisole medicines over risk of rare, deadly brain disorder

The recommendation is based on new data from continuous safety monitoring of medicines in the EU

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

Agilent’s PD-L1 test gains FDA nod for ovarian cancer

This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA

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