regulatory approval

News

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

News

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

News

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.

News

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

News

Eisai and Biogen get FDA approval for subcutaneous Leqembi. Will it help stave off growing competition from Lilly's Kisunla in Alzheimer's treatment?