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Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
The FDA has approved an oral form of Wegovy, expanding treatment options for obesity.
The FDA has approved Myqorzo, marking Cytokinetics’ first drug clearance for obstructive hypertrophic cardiomyopathy.
The FDA has issued a partial clinical hold on the I-DXd trial for small cell lung cancer following unexpected patient deaths.
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.