Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
Full approval will depend on verification of clinical benefit in a confirmatory trial
The additional production will raise the installed capacity by 400 million and available capacity by 240 million at the facility
The initiative is focused on a problem that continues to plague cancer outcomes in India
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
The study found BIC/LEN to be statistically non-inferior to BIKTARVY, Gilead’s current standard-of-care therapy
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
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