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
Adverse events were consistent with valbenazine’s established safety profile
The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy
FOP is a rare genetic disorder caused by mutations in the ALK2 kinase
GSK will make most of its inhaled respiratory portfolio and other products available on a direct purchasing platform, offering savings of up to 66%
The said certificate is valid for a period of 3 years and opens up the European and other markets for the company's products
At the heart of the showdown is a deep split among federal circuit courts over whether federal law overrides state failure-to-warn claims in Roundup personal-injury suits
Topline results from the Phase 2 VISTA trial show that PIPE-307 did not meet its primary or secondary efficacy endpoints
Building a transparent, data-driven supply chain and self-reliant API ecosystem remains critical to reducing import dependence
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