Caliway has completed the End-of-Phase 2 (EOP2) meeting with the U.S. FDA for CBL-514, the world's first investigational drug for large-area subcutaneous fat reduction developed under the 505(b)(1) ...

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

There could be an upside to incorporating AI for the FDA. Using AI to assist in final drug reviews would "represent a chance ...

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.

Researchers at the Paul Scherrer Institute PSI have developed an AI that could open up a new, cost-effective approach to ...

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

Mineralys Therapeutics, Inc. ( NASDAQ: MLYS) Q1 2025 Earnings Conference Call May 12, 2025 4:30 PM ET ...

Belite Bio, Inc (NASDAQ: BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet ...

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” ...