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 ...

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

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, ...

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 US FDA has approved mosunetuzumab-axgb (Lunsumio VELO) as a subcutaneous (SC) formulation for the treatment of adult ...

Poherdy can be dispensed as a substitute for Perjeta without requiring a prescription change from a health care provider.

The FDA is expected to decide on treatments for breast cancer, EBV+ post-transplant lymphoproliferative disease, focal segmental glomerulosclerosis, presbyopia, and severe allergic reactions.

Walz decision not to seek a third term comes amidst allegations of fraud with federal dollars in Minnesota. In November, a ...