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

Quantum BioPharma completes key toxicity studies for Lucid-MS, paving way for Phase 2 MS trial

Lucid-MS represents a potential breakthrough in the treatment of multiple sclerosis

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

Lupin and Gan & Lee enter exclusive licensing deal for novel GLP-1 receptor agonist

Lupin has bolstered its diabetes and obesity portfolios by securing an agreement for Bofanglutide, a GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals

Intas and IntegriMedical to launch India’s first needle-free injection system for IVF and gynaecology

Intas becomes the first and only company in India to offer IVF and gynecology therapies with needle-free injections

FDA setback for Sanofi’s Tolebrutinib in progressive MS

Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity

EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP

Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation

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

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR