Kura Oncology won FDA priority review for its drug the day before announcing new data at ASCO 2025 showing remission in about ...

The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for ziftomenib, an investigational ...

Although the FDA has rejected Stealth’s new drug application for Barth syndrome candidate elamipretide, the agency identified ...

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

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 ...

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

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

Rigorous answers about the program’s effects on drug innovation are still a ways off. However, some information about ...

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 ...

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

A new NDA was submitted in January 2024, which the FDA did accept, and that was later converted into a priority review. An ...

DOGE staffers reportedly left weed in the U.S. Institute of Peace, after forcibly taking over the organization earlier this ...