regulatory approval

News

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.

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Johnson & Johnson has brought its bladder cancer drug TAR-200 to the US market, a year after its prospects were dented by a negative phase 3 readout.

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Sanofi's BTK inhibitor Wayrilz has become the first drug in the class to be approved for rare platelet-busting disease immune thrombocytopenia.