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

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

Health Minister Nadda to launch Indian Pharmacopoeia 2026 in the first week of Jan. 2026

Indian Pharmacopoeia is now recognised in 19 countries, reflecting growing international confidence in India’s regulatory and scientific capabilities

Nona Biosciences expands platform to accelerate early clinical trials

Nona aims to help global biopharmaceutical companies fast-track clinical trial initiation without compromising scientific rigor or quality standards

Ginkgo Bioworks teams with Carnegie Mellon on cancer detection program

The collaboration aims to combine synthetic biology with cutting-edge detection technology to create a first-of-its-kind oral pill embedded with tumor-targeting sensors

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

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

Amneal and mAbxience score FDA green light for two Denosumab biosimilars