Chembio’s antibody test is the first to have its authorisation revoked. It might not be the last.
An advisory panel votes to pull Amag’s Makena from the market, but will the US regulator follow through?
Transvaginal mesh implants are banned in the US, but remain a possibility in Europe.
Bayer's only remaining medical technology franchise is its radiology business.
The FDA's shifting stance on the efficacy of PD-(L)1 drugs in first-line urothelial bladder cancer does little for those worried about the agency loosing its teeth.