FDA setback for Sanofi’s Tolebrutinib in progressive MS
Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation
The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
The move strengthens Sanofi’s presence in adult immunization by combining Dynavax’s innovative vaccines with Sanofi’s global scale and development capabilities
Study published in laboratory investigation, the official journal of the United States and Canadian Academy of Pathology
AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life
The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo
Under the 2023 collaboration agreement, Assembly Bio will receive $35 million for Gilead’s exercise of the HSV program option
If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant
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