Sanofi’s Amlitelimab delivers in Phase 3 trials, heads for global filings
In the SHORE phase 3 study, amlitelimab, used in combination with topical therapies, met all primary and key secondary endpoints at Week 24
In the SHORE phase 3 study, amlitelimab, used in combination with topical therapies, met all primary and key secondary endpoints at Week 24
This marks the second indication for which gumokimab has gained NDA review acceptance
Galenicum will oversee development, manufacturing and supply, while Lupin will handle regulatory submissions, approvals, and commercialization and distribution of Semaglutide across 23 countries globally
Favorable outcome would contribute to significantly containing the Roundup litigation as the company continues its multi-pronged strategy
BioNTech is positioning 2026 as a defining year in its transition toward a multi-product oncology company
The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes
Vanda strongly disputes the FDA’s reasoning
The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market
The approval is backed by data showing deep, durable responses and manageable tolerability
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