regulatory approval

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.

News

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?

News

Ionis gets FDA nod for its HAE attack prophylactic treatment Dawnzera, offering less frequent dosing than its rivals.