FDA Needs Additional Time to Review Sparsentan, Tofersen Applications
The target action dates have been extended by 3 months to allow for extra time to review the applications.
Diagnosis & Disease Information
Oxlumo Indication Expanded to Include Patients With Advanced PH1
The approval was based on data from the phase 3 ILLUMINATE-C study that included 21 dialysis-independent and -dependent patients with PH1.
FDA Approves Oral Testosterone Replacement Therapy Kyzatrex
The FDA has approved Kyzatrex (testosterone undecanoate) for the treatment of primary and secondary hypogonadism in adult males.
Sesen Bio Puts Development of Bladder Cancer Drug Vicineum on Pause
The Biologics License Application (BLA) for Vicineum included preliminary findings from the phase 3 VISTA trial.
FDA Needs More Data on Tebipenem HBr for Complicated UTI
In the CRL, the FDA stated that the application could not be approved in its present form and that an additional clinical trial would be required.
Sacituzumab Govitecan Plus Pembrolizumab Promising for Metastatic Urothelial Cancer After Failure With Platinum-Based Regimen
Cohort 3 of the phase 2 TROPHY-U-01 trial evaluated sacituzumab govitecan plus pembrolizumab in checkpoint inhibitor-naive adults with metastatic urothelial cancer who progressed after platinum-based chemotherapy.
FDA Says No to Vadadustat Approval Due to Safety Concerns
The NDA submission included data from 36 clinical trials involving over 8000 patients.
Pembrolizumab Plus Lenvatinib Not Superior to Pembrolizumab Alone in Advanced Urothelial Carcinoma
The phase 3 LEAP-011 study evaluated pembrolizumab plus lenvatinib vs placebo in 441 adults with histologically confirmed, locally advanced or metastatic urothelial carcinoma.
Positive Efficacy Findings Prompt Early Stop of Empagliflozin CKD Trial
The EMPA-KIDNEY study enrolled more than 6600 patients with CKD attributable to a wide range of underlying causes.
Cefepime-Taniborbactam Bests Meropenem in Complicated UTI Trial
The phase 3 CERTAIN-1 study compared the efficacy and safety of cefepime-taniborbactam to meropenem in 661 adults with cUTI.
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