regulatory

News

Court sides with EU on decision to revoke Ocaliva's license

Advanz Pharma's bid to keep its Ocaliva treatment for rare liver disease primary biliary cholangitis (PBC) on the EU market has ended in failure

News

Is Martin Makary Trump's pick for FDA Commissioner?

US President-elect Donald Trump is reported to be considering the nomination of Johns Hopkins surgeon and writer Martin Makary to lead the FDA

News

A lukewarm response, graphic of man shrugging

FDA experts lukewarm on AZ's anticoagulant antidote Andexxa

AstraZeneca is facing some pushback as it tries to upgrade anticoagulant antidote drug Andexxa to full approval in the US

News

FDA says no to Astellas' geographic atrophy drug

Astellas has suffered another major setback with geographic atrophy (GA) treatment Izervay, this time in the US.

News

Scrabble letters spelling out 'Learn from failure'

Daiichi and AZ pull Dato-DXd filing with FDA and try again

Nine months after filing their TROP2-directed antibody-drug conjugate Dato-DXd for a lung cancer indication with the FDA, Daiichi Sankyo and AstraZeneca have pulled the submission.

News

Unicycive eyes June FDA verdict for hyperphosphataemia drug

The FDA has started a review of Unicycive Therapeutics' drug for hyperphosphataemia in patients with chronic kidney disease (CKD) who need dialysis, which hopes to improve on 'onerous' phos

Court sides with EU on decision to revoke Ocaliva's license

Is Martin Makary Trump's pick for FDA Commissioner?

FDA experts lukewarm on AZ's anticoagulant antidote Andexxa

FDA says no to Astellas' geographic atrophy drug

Daiichi and AZ pull Dato-DXd filing with FDA and try again

Unicycive eyes June FDA verdict for hyperphosphataemia drug

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

regulatory

Editor's Picks