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

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 ...

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

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

A Phase I/II trial is set to assess the therapy’s potential efficacy and safety, as well as determine an appropriate dose.

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 ...

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

Few areas of healthcare are as sensitive as cancer treatment. Each year, around 44,000 cancer tumours are diagnosed here.

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 public should closely watch potential fluctuations of medicine prices should Washington proceed with a plan to cut ...