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Neuracle Technology receives world-first approval in China for brain-computer interface system treating spinal cord injuries
Medical device, neurological, brain-computer interface, spinal cord injury, paralysis - Read more

GSK's Arexvy wins FDA label expansion for respiratory syncytial virus in high-risk adults under 50
Vaccine, infectious disease, respiratory syncytial virus, protein-based vaccine, high-risk adults - Read more

Novartis wins FDA approval for Cosentyx (secukinumab) in pediatric patients with moderate to severe hidradenitis suppurativa
Antibody, autoimmune, monoclonal antibody, hidradenitis suppurativa, IL-17A inhibitor, pediatric patients - Read more

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Sana Biotechnology's UP421 islet cell therapy shows sustained insulin production at 14 months in Type 1 diabetes patient
Cell therapy, metabolic, islet cell transplantation, Type 1 diabetes, hypoimmune technology, insulin production - Read more

Gubra launches Gubra Ventures unit to incubate new biotechs using Roivant-like asset-centric company model
Metabolic therapy, obesity, strategic, incubation model - Read more

Unixell Biotechnology receives FDA approval to initiate Ph1 trial of allogeneic stem cell therapy for drug-resistant epilepsy
Cell therapy, neurological, allogeneic stem cells, drug-resistant epilepsy, GABA - Read more

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FDA rejects Hyloris Pharmaceuticals' valacyclovir oral suspension for herpes simplex and varicella zoster virus infections
Small molecule, infectious disease, antiviral, herpes simplex virus, manufacturing issues - Read more

Immutep halts Ph3 trial of eftilagimod alfa (LAG-3 agonist) for non-small cell lung cancer due to futility
Protein therapy, cancer, LAG-3 agonist, non-small cell lung cancer, combination therapy, PD-1 inhibitor - Read more

Y-mAbs terminates Ph1 radiopharmaceutical trial in non-Hodgkin lymphoma due to recruitment challenges
Radiopharmaceutical, cancer, monoclonal antibody, non-Hodgkin lymphoma, neuroblastoma - Read more

Inovio Pharmaceuticals cuts staff as FDA questions INO-3107's accelerated approval pathway eligibility for rare disease treatment
DNA therapy, rare disease, operational, regulatory - Read more

U.K. watchdog rules Bayer discredited pharma industry with pre-license Eylea HD promotion after Roche complaint
Monoclonal antibody, ophthalmology, competitive, regulatory - Read more

FDA issues warning letter to Simtra Biopharma Solutions over contamination failures at German facility
Manufacturing services, regulatory, operational, contamination - Read more

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