The US FDA gets tough
Tecentriq follows Opdivo, Imfinzi and Keytruda in having a US approved use knocked out.
Despite Imfinzi, US accelerated approvals surge
More and more drugs are being approved conditionally on flimsy data, and Imfinzi is just the second to be pulled after failing a confirmatory trial.
Boston deadheads its Lotus
Beset with problems from the off, the Lotus Edge aortic valve has finally been discontinued.
The FDA gets aggressive with Covid-19 antibody tests
Chembio’s antibody test is the first to have its authorisation revoked. It might not be the last.
A chance for the US regulator to show its teeth, at Amag’s expense
An advisory panel votes to pull Amag’s Makena from the market, but will the US regulator follow through?
Boston and Coloplast sink on mesh mess
Transvaginal mesh implants are banned in the US, but remain a possibility in Europe.
Bayer’s second-to-last medtech stream dries up
Bayer's only remaining medical technology franchise is its radiology business.
Will the real FDA please stand up
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.
