The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid ...

Tenpoint Therapeutics, Ltd. ("Tenpoint"), a global, clinical-stage biotechnology company focused on developing groundbreaking treatments to rejuvenate vision in the aging eye, today announces that the ...

Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) and granted Priority Review designation for the investigational compound ...

Khindivi is the sole FDA-approved hydrocortisone oral solution and is available in a 1mg/ml concentration. This formulation ...

This patent strengthens Renovaro's AI and machine learning intellectual property portfolio by protecting novel methods for ...

Preclinical data has showing compelling findings for HT-KIT among patients with rare and aggressive KIT-driven cancers, ...

The FDA has accepted for priority review the new drug application for sevabertinib (BAY 2927088) to treat certain patients with NSCLC.

- The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would provide a significant ...

The trial will evaluate AXPAXLI in at least 555 patients in a multi-center, double-masked, randomized (2:2:1), 3-arm study.

ND0612 is an investigational drug-device therapy that provides a 24-hour continuous subcutaneous infusion of levodopa/carbidopa solution. The Food and Drug Administration (FDA) has accepted for review ...

has accepted the New Drug Application (NDA) resubmission for investigational ND0612, a 24-hours/day, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD), for the treatment ...

SMMT's HARMONi trial shows PFS benefits for ivonescimab in EGFR-mutant NSCLC, but lack of proven overall survival raises ...