Clinical Advisor

FDA Grants Breakthrough Designation to Ianalumab for Sjögren Disease

FDA grants Breakthrough Therapy designation to ianalumab for Sjögren disease after the monoclonal antibody showed significant disease improvement.
Targeted Oncology

FDA Grants Priority Review to Gedatolisib for Advanced Breast Cancer

Gedatolisib's NDA for advanced breast cancer treatment has been accepted by the FDA, with a priority review and a PDUFA date set for July 17, 2026. The drug is intended for HR+/HER2–, PIK3CA wild-type ...
Frontiers

From Dish to Disease: Human organoid models for advancing gene therapy in neurodegenerative disorders

Neurodegenerative diseases (NDDs) represent a profound challenge to global health, characterized by progressive neuronal dysfunction and loss, leading to ...
Santé log

Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data

FDA has requested the HOPE-3 clinical study report (CSR) as part of the BLA review process; Company expects to submit updates to the BLA in February 2026 to support continued FDA ...