Lilly obesity pill orforglipron is under FDA review with a decision expected in Q2 2025, aiming to compete with Novo Nordisk’s offerings.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
GSK Ionis hepatitis B drug advances to global regulatory filings, aiming for functional cures in chronic infections.
FDA approval decisions in early 2026 include multiple national priority vouchers and a gene therapy, impacting the pharmaceutical landscape.
Moderna mRNA flu vaccine seeks US approval, aiming to boost growth in the coming years.
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.