FibroBiologics moves experimental psoriasis therapy into FDA review

The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline

Mabwell’s groundbreaking anti-IL-11 antibody enters Phase II trials for pathological scarring

The Phase II study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of 9MW3811 in patients with pathological scarring

SOFIE Biosciences doses first patient in Phase 3 trial of novel cancer imaging agent

The study will run across 18 sites and enroll roughly 200 patients over 24 months

GenSight Biologics gets early access nod for candidate gene therapy in Israel

Applications include detailed scientific rationale and supporting clinical evidence

Biohaven reports Phase 2 depression trial results

Despite some promising subgroup signals, the company indicated it will not pursue further psychiatric trials

INOVIO’s DNA therapy for rare throat disease gets FDA review

INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway

Senhwa Biosciences launches groundbreaking trial for HER2-positive tumours

CX-5461 is “the world's first and most advanced G-quadruplex (G4) stabilizer in development

SN Bioscience’s SNB-101 wins FDA orphan drug designation for gastric cancer

The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38

ENHERTU gains first-ever nod in China for metastatic breast cancer

The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy

US House passes Bill reauthorizing FDA rare disease incentive program