urologytimes

Atish Choudhury, MD, PhD, highlights phase 2 data on treatment interruption in mHSPC

Atish D. Choudhury, MD, PhD, discusses findings from the A-DREAM / Alliance A032101 trial evaluating treatment interruption following favorable response to combination ADT and ARPI therapy in mHSPC.
urologytimes

FDA grants tentative approval to generic enzalutamide tablets

Tentative FDA approval enables Lupin to prepare for commercial launch of generic enzalutamide once remaining exclusivity and patent constraints no longer block approval. Bioequivalence was established ...
urologytimes

HHS requests testosterone therapy label updates, citing new safety data

Labeling would drop the limitation of use for age-related hypogonadism, reflecting an evidence reassessment that no longer supports language implying unestablished safety and effectiveness in this ...
urologytimes

FDA approves tebipenem pivoxil for complicated urinary tract infections

The approval is supported by data from the phase 3 PIVOT-PO trial, in which tebipenem demonstrated noninferiority to imipenem-cilastatin. This decision marks the first approval of an oral carbapenem ...
urologytimes

Praful Ravi, MB, BChir, MRCP, on PSMA-PET during initial systemic therapy for mHSPC

Praful Ravi, MB, BChir, MRCP, discusses results from PSMAtrack, which assessed changes in PSMA-PET during initial systemic therapy for metastatic hormone-sensitive prostate cancer. According to Ravi, ...
urologytimes

FDA approves adjuvant belzutifan with pembrolizumab for ccRCC

The application is supported by data from the phase 3 LITESPARK-022 trial. The FDA has approved belzutifan (Welireg) in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase ...