ETX-19477 is a potent, selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG), an enzyme that plays a role in the DNA ...
The FDA and European Medicines Agency (EMA) have awarded orphan drug designation to CPI-008 (cRGD-ZW800-1), a novel ...
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 ...
Walz decision not to seek a third term comes amidst allegations of fraud with federal dollars in Minnesota. In November, a ...
New analysis of a Phase 3 study of daridorexant shows that 50 mg improved both sleep and daytime functioning compared to placebo in women during menopausal transition ageBrigham and Women's Hospital t ...
Seasoned dermatology and immunology executive brings more than 25 years of experience advancing and launching innovative ...
For patients with Waldenström macroglobulinemia (WM), transitioning from ibrutinib (Imbruvica) to zanubrutinib (Brukinsa) may offer comparable clinical outcomes, as suggested by interim data from a ...
A new drug application (NDA) has been submitted to the FDA seeking approval of rusfertide, an investigational hepcidin ...
“Orforglipron and retatrutide from Eli Lilly exemplify the next generation of metabolic therapies: oral formulations that promise improved adherence, triple-hormone mechanisms that deliver superior ...
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 ...
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