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.
Energenesis and Taiwan Tanabe advance ENERGI-F703DFU development as the Phase III diabetic foot ulcer program moves toward a Taiwan NDA.
Northwest Biotherapeutics and SPIMACO target a Saudi DCVax-L pathway. See what the MOU means for approval and local manufacturing.
Senhwa Biosciences has secured Taiwan regulatory clearance for a multicenter Phase 1b/2a trial combining pidnarulex, or CX-5461, with BeOne Medicines’ PD-1 inhibitor tislelizumab in advanced solid tumors. The study will test whether DNA replication stress can make immunologically cold or checkpoint-resistant cancers more responsive to immunotherapy.
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
KKR’s €1.2 billion Medicover India deal targets a 24-hospital platform as private capital accelerates India’s healthcare consolidation.
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.