Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy

N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway

Eyestem moves closer to blindness breakthrough with phase 2 trial green light

The early-stage trial demonstrated an excellent safety profile alongside clinically meaningful improvements in visual acuity

Trelegy Ellipta gets green light in China for adults with uncontrolled asthma

The approval expands the drug’s existing COPD indication, making it the only single-inhaler triple therapy (SITT) available for both respiratory conditions in China

EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C

The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients

MRM Health scores FDA green light to launch Phase 2b trial of groundbreaking UC therapy

MH002, a rationally designed live microbial consortium, combines six well-characterized commensal strains to target disease-specific mechanisms

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations

Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy

REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS

InnoCare Pharma gets green light for Phase II trial of oral lupus drug

CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions

Chugai’s Tecentriq gets green light in Japan for hard-to-treat Thymic Carcinoma

The drug had previously received orphan drug designation for this rare cancer on March 31, 2025

Amneal and mAbxience score FDA green light for two Denosumab biosimilars