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 SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR
The move strengthens Sanofi’s presence in adult immunization by combining Dynavax’s innovative vaccines with Sanofi’s global scale and development capabilities
Under the terms of the deal, AstraZeneca gains exclusive rights to JAB-23E73 outside of mainland China
Under the 2023 collaboration agreement, Assembly Bio will receive $35 million for Gilead’s exercise of the HSV program option
Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy
NUFYMCO BLA has been approved by the USFDA
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