RiboX Therapeutics has received clearance from the United States Food and Drug Administration to begin clinical testing of RXIM002, an experimental treatment designed to create temporary anti-CD19 CAR-T cells directly inside the body of a patient with autoimmune disease. The August 8, 2026 investigational new drug clearance allows RiboX Therapeutics to initiate the Phase 1
The United States Food and Drug Administration (FDA) has granted accelerated approval to Replimune Group’s Tudriqev in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed during a programmed death receptor-1 blocking treatment. The August 6, 2026 decision gives oncologists a new option for a difficult stage of melanoma treatment, when tumours
IPS HEART gains FDA rare pediatric designation for ISX9-CPC, but the iPSC heart therapy remains preclinical as human testing becomes the key hurdle.
Australian medical robotics company Vexev has raised $6 million to support FDA regulatory work, manufacturing scale-up and U.S. commercialization of VxWave after a multicenter study showed that dialysis-clinic staff could perform semi-autonomous vascular scans with the investigational system.
Takeda Pharmaceutical Company Limited has secured United States Food and Drug Administration approval for ORZEYFUL, or oveporexton, the first oral orexin receptor 2 agonist authorised to treat narcolepsy type 1 as a complete disorder in adults. The approval introduces a new treatment mechanism, but the medicine will not become available until the Drug Enforcement Administration
Weekly navepegritide combination sustains growth through 78 weeks in achondroplasia. Read what the small COACH trial shows and cannot prove.
Bezisterim improves motor, non-motor and inflammatory measures in a small Parkinson’s trial. Read what the data show and why doubts remain.
Aravax has secured United States Food and Drug Administration Fast Track designation for PVX108, an investigational peptide immunotherapy designed to retrain peanut-specific immune responses without containing whole peanut proteins or allergen extracts. The regulatory milestone increases the importance of Phase 2 results expected later in 2026.
LX2020 gains FDA RMAT status after early PKP2 heart data. Read what the designation changes and why the evidence remains preliminary.
ACR-2316 enters randomized expansion after early lung cancer responses. Read how Acrivon will compare two weekly doses across six tumor groups.