The FDA has issued a partial clinical hold on the I-DXd trial for small cell lung cancer following unexpected patient deaths.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
The application targets obesity treatment in the U.S. market.
Cytokinetics FDA approval marks a milestone with Myqorzo, challenging Bristol Myers’ Camzyos in the heart drug market.
Merck Daiichi FDA hold impacts ADC trial for small cell lung cancer due to unexpected patient deaths.
Novo Nordisk has filed for approval of its obesity drug CagriSema.
Novo Nordisk oral Wegovy receives FDA approval, marking a significant step in the obesity drug market.
Cytokinetics FDA approval marks a milestone with Myqorzo, challenging Bristol Myers’ Camzyos in the heart drug market.
Merck and Daiichi Sankyo’s I-DXd trial faces FDA hold due to unexpected death rates in small cell lung cancer study.
Novo Nordisk FDA approval for oral Wegovy marks a significant step in the obesity drug market, outpacing competitors.
Cytokinetics FDA approval marks its first drug clearance, challenging Bristol Myers’ Camzyos in the heart drug market.