Silintan capsules, a dietary supplement tainted with an anti-inflammatory drug, have been recalled, according to the Food and ...

Fresenius Kabi, an Operating Company of Fresenius, and a leading provider of essential medicines and medical technologies, ...

ETX-19477 is a potent, selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG), an enzyme that plays a role in the DNA ...

Q. I would like to know more about the use of testosterone replacement in men. My understanding is that a recent large-scale study showed that men using testosterone replacement therapy did not have ...

Exploring clinical development plan options including a controlled human infection model (CHIM) and a Phase 2/3 adaptive ...

TRITON3 trial data support FDA traditional approval of rucaparib for treating adults with BRCA-mutated metastatic castration-resistant prostate cancer.

At the federal level, the U.S. Food and Drug Administration finally removed the “black box warning” on estrogen products, ...

MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License ...

The Food and Drug Administration has approved Nereus (tradipitant) for the prevention of vomiting induced by motion in adults.

The FDA has granted breakthrough therapy designation (BTD) to sevabertinib (Hyrnuo, formerly BAY 2927088) for the first-line ...

The FDA and European Medicines Agency (EMA) have awarded orphan drug designation to CPI-008 (cRGD-ZW800-1), a novel ...

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ('Tonix” or the 'Company”), a fully-integrated commercial stage biotechnology company, today announced it has entered into a securities purchase ...