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
Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients
The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort
MRI is particularly valuable in pediatric care due to its non-invasive nature
Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis
Topline results from the Phase 2 VISTA trial show that PIPE-307 did not meet its primary or secondary efficacy endpoints
The Eurasian Patent Organization (EAPO) has granted Patent, protecting the company’s sublingual delivery technology for anticancer drugs used to treat autoimmune and neurodegenerative diseases
Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis
Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
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