regulatory approval

News

Novartis has claimed a first-in-class approval in the US for its oral BTK inhibitor remibrutinib as a treatment for chronic spontaneous urticaria.

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Lilly's Inluriyo is the second oral SERD to reach the US market for ESR1-mutated breast cancer, setting up a market tussle with Menarini's Orserdu.

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Biolinq gets an FDA green light for its autonomous, needle-free continuous glucose monitor, plus a roundup of other medtech developments.

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After a long haul, Stealth BioTherapeutics has finally claimed FDA approval for Forzinity, the first treatment for ultra-rare disease Barth syndrome.

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MSD's Keytruda will soon be available as a subcutaneous injection, improving convenience for patients and defending it from a looming patent loss.

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Novo Nordisk's Rybelsus has become the first oral GLP-1 agonist to pick up a regulatory approval for cardiovascular risk reduction.