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

Early entry of RAS-targeting franchise into clinic enabled by strong execution Initial Phase 1 monotherapy data for pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 expected in 2026 ...

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.

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

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.

The FDA cleared the investigational new drug application of IDE849, a potential first-in-class DLL3-targeted antibody-drug ...

We recently compiled a list of the 11 Stocks That Will Bounce Back According To Analysts. In this article, we are going to ...