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

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

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

Biofabri and Bharat Biotech ink tech transfer pact to boost global TB vaccine access

BBIL will guarantee production and supply of MTBVAC to more than 70 countries across Africa and Southeast Asia

Emcure Pharma launches weight loss drug Poviztra in India

Emcure becomes the first Indian company to exclusively distribute and commercialise Poviztra, a second brand of Novo Nordisk’s Semaglutide injection for weight management

Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus

The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation