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.

IND cleared for pan-RAS molecular glue ERAS-0015 and IND submitted for pan-KRAS inhibitor ERAS-4001, both ahead of schedule; Phase 1 monotherapy data for both programs expected in 2026 Meaningful ...

The Evidence-Based Drug Policy Act of 2025 seeks to remove federal barriers to researching Schedule I substances like ...

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

President Donald Trump signed an executive order on Monday aimed at lowering prescription drug prices in the U.S. Here's what ...

Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat ...

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