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 drug had previously received orphan drug designation for this rare cancer on March 31, 2025
The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR
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
U.S. and Canada transaction supports continued access to RADICAVA for people living with ALS
Under the terms of the deal, AstraZeneca gains exclusive rights to JAB-23E73 outside of mainland China
The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo
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