Cytokinetics' PDUFA date for aficamten was extended to December 26th of 2025, due to the FDA's need to review a submitted ...

FDA seeking 'aggressive' adoption of AI . The FDA announced an "aggressive timeline" to deploy artificial intelligence ...

Quantum Biopharma plans to file an application by year's end seeking FDA clearance for a Phase 2 clinical trial testing Lucid ...

This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development.

The investigational transdermal delivery system, known as Xulane Lo, is designed to deliver 150mcg of norelgestromin and 17.5mcg of ethinyl estradiol per day.

Financial Results As of March 31, 2025, the company’s cash, cash equivalents, and marketable securities were $23.2 million. Total operating expenses for the quarter ended March 31, 2025 were $12.9 ...

Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...

UroGen Pharma nears FDA approval for UGN-102, targeting a $5B market. Discover insights on Q1 2025 earnings, launch readiness, and the upcoming ODAC review.

The Food and Drug Administration (FDA) recently announced that it had identified “significant data integrity and study conduct concerns” ...

The FDA has cleared investigational new drug applications and handed out fast track designations. Plus, data shows promise for novel therapies in hard-to-treat cancers.