News

January 13, 2026The U.S. Food and Drug Administration (FDA) has declined to approve Atara Biotherapeutics’ cell therapy tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant ...

January 2026The U.S. Food and Drug Administration (FDA) has announced an updated regulatory approach aimed at increasing flexibility in the development and manufacturing oversight of cell and gene the...

SANTA ANA, Calif., Jan. 10, 2026 – NKGen Biotech, Inc., a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for...

Johnson & Johnson has reached an agreement with the U.S. government to lower prices on select prescription drugs, marking a significant development in ongoing negotiations between the pharmaceutic...

January 6, 2026 — Boston — Biotech company Variant Bio announced on Tuesday the launch of a new artificial intelligence-driven platform designed to accelerate the discovery and development of new dr...

Washington, Dec. 24, 2025 — The U.S. Food and Drug Administration has approved Yartemlea, a monoclonal antibody developed by Omeros Corporation, as the first treatment for transplant-associated throm...

The United Arab Emirates has become the second country in the world to approve the gene therapy Itvisma for the treatment of spinal muscular atrophy (SMA), marking another milestone in the global adop...

Paris / Seoul — Dec. 15, 2025 — French pharmaceutical company Sanofi has entered into a strategic collaboration with South Korean biotech firm ADEL worth up to USD 1.04 billion to jointly develop an...

Durham, NC — Dec. 12, 2025 — The U.S. Food and Drug Administration (FDA) has approved an oral pellet formulation of Orladeyo (berotralstat) from BioCryst Pharmaceuticals for prophylactic use in chil...

Washington, Dec. 9, 2025 — The U.S. Food and Drug Administration (FDA) has approved Waskyra (etuvetidigene autotemcel), a gene therapy developed by nonprofit organization Fondazione Telethon ETS, for...

Boston, December 6, 2025Vertex Pharmaceuticals announced new clinical data demonstrating that its gene-editing therapy Casgevy (exagamglogene autotemcel, exa-cel) produced robust therapeutic benefits ...

December 3, 2025 — Capricor Therapeutics announced that its investigational cell therapy Deramiocel achieved both primary and key secondary endpoints in the pivotal Phase 3 HOPE-3 trial for Duchenne ...