regulatory approval

News

The FDA has approved Bristol Myers Squibb's Opdivo and Yervoy as first-line therapy for patients with a particular form of colorectal cancer.

News

Brainomix has been granted FDA approval for a new feature for its AI-powered stroke imaging software that could unlock wider use in the US.

News

AbbVie has picked up another indication for its JAK inhibitor Rinvoq in the EU, becoming the first approved oral therapy for giant cell arteritis.

News

AstraZeneca and Daiichi Sankyo have claimed approval from the European Commission for Datroway, their TROP2-directed ADC for breast cancer.

News

AstraZeneca is celebrating two approvals for cancer drugs Imfinzi and Enhertu in the EU as it faces increased competition to its top-seller Tagrisso.

News

Amgen has bagged a second indication for its B cell-depleting therapy Uplizna after the FDA cleared it for rare inflammatory disease IgG4-RD.