Flibanserin (Addyi) is now approved for treating HSDD in postmenopausal women, expanding its previous indication for premenopausal women. The FDA's priority review designation for flibanserin ...
The FDA approved niraparib with abiraterone acetate and prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer based on the AMPLITUDE trial results. The trial demonstrated ...
Gepotidacin is now approved for treating uncomplicated urogenital gonorrhea in patients 12 years and older, expanding its previous approval for urinary tract infections. The EAGLE-1 trial showed ...
The group agreed that the future of NMIBC treatment depends on biomarkers that can direct patients toward the therapy most likely to work. The group agreed that treatment selection for ...
IsoPSA, a blood-based test, aids in diagnosing high-grade prostate cancer by analyzing PSA protein structural variants. FDA approval was based on a large-scale, prospective study and other validation ...
"Based on the code description, we recommend basing the code selection on the documentation and the effort required to complete the service, and not the number of foreign bodies removed from the ...
The approval is supported by results from the phase 3 KEYNOTE-905/EV-303 trial. On November 21, 2025, the FDA approved pembrolizumab (Keytruda) and pembrolizumab and berahyaluronidase alfa-pmph ...
IsoPSA test analyzes prostate cancer-specific structural variants of PSA protein to aid biopsy decisions in men over 50 with elevated PSA levels. The FDA approved IsoPSA based on a large-scale, ...
YOLT-203 is an investigational gene-editing therapy for PH1, aiming to reduce oxalate overproduction by deactivating glycolate oxidase. The pivotal trial will assess YOLT-203's safety and efficacy in ...
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