Itolizumab Receives Fast Track Status for Lupus Nephritis
The FDA has granted Fast Track designation for itolizumab (EQ001; Equillium) for the treatment of lupus nephritis.
Urologic Disorders
Renal Impairment Labeling Updates for Sofosbuvir-Based HCV Therapies
The FDA has approved updated labeling for Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to include updated information regarding treatment of patients with hepatitis C virus (HCV) who have severe renal impairment including those with end stage renal disease who are on dialysis.
Ultomiris Receives Approval for Atypical Hemolytic Uremic Syndrome
The FDA has approved Ultomiris (ravulizumab-cwvz; Alexion) for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric patients aged 1 month and older.
Diabetes Tx Gains Fast Track Designation for Kidney Disease
The FDA has granted Fast Track designation to dapagliflozin (Farxiga; AstraZeneca) as a possible treatment to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease.
Quality of Life Outcomes Comparable Regardless of Treatment With HRT or CRT for Low-Risk Prostate Cancer
Hypofractionated radiotherapy (HRT) offers quality-of-life outcomes similar to conventional radiation therapy for men with low-risk prostate cancer, according to recently published results of a phase 3 randomized study. HRT offers a less expensive and more convenient treatment option for some patients, and in light of the new findings about quality of life, should be considered…
ProVate Gets FDA Approval to Treat Pelvic Organ Prolapse
The FDA has approved ProVate (ConTIPI) for the temporary, nonsurgical management of pelvic organ prolapse in women.
Thiola EC Approved for Treatment of Cystinuria
A new enteric-coated formulation of Thiola has been approved by the Food and Drug Administration for the prevention of cystine stone formation.
Certain Clinical Factors Up Risk for Urethral Stricture Complications
In a cohort study, 7% of patients had life-threatening complications associated with urethral stricture.
Selective Estrogen Receptor Modulators May Be Effective for Male Infertility
Selective estrogen receptor modulators (SERMs) may be effective for treating male infertility, according to a recent systematic review and meta-analysis published in Expert Opinion on Pharmacotherapy. SERMs are compounds that exhibit tissue-selective estrogen receptor agonist and antagonist activity. Clomiphene citrate and tamoxifen are two agents commonly used for the off-label management of male infertility. To…
New Oral Tx Approved for Males With Certain Types of Hypogonadism
The Food and Drug Administration (FDA) has approved Jatenzo (testosterone undecanoate; Clarus Therapeutics) capsules for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
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