Biohaven reports Phase 2 depression trial results

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

Edgewise Therapeutics reports positive updates from HCM drug EDG-7500

CIRRUS-HCM, an open-label, multi-part study, evaluates EDG-7500 in patients with obstructive and nonobstructive HCM

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

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

Symbiosis rolls out first 10,000 vial batch at Stirling Facility

This production milestone positions Symbiosis at the forefront of meeting rising global demand for life-saving medicines

IRLAB launches Phase Ib Trial of IRL757 for Parkinson’s patients with Apathy

The multicenter study will enroll 75 patients across 16 sites in Germany, Bulgaria, Poland, and Spain

FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia

The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia

Sanofi to acquire Dynavax in $2.2 billion deal, bolstering adult vaccine portfolio

The move strengthens Sanofi’s presence in adult immunization by combining Dynavax’s innovative vaccines with Sanofi’s global scale and development capabilities