The Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for MCNA (Telesta) as a therapeutic alternative to surgery in high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy.
A review in the journal Endocrine Reviews and Metabolic Disorders reports that greater education and awareness of the potential risks associated with two treatments for benign prostate hyperplasia (BPH) is needed among both patients and clinicians, along with additional research exploring these reported adverse effects.
The Food and Drug Administration (FDA) has approved changes to the Myrbetriq (mirabegron; Astellas Pharma) label to include a new contraindication and a new update to the Warnings and Precautions section.
Blue Square Market, Inc. announced voluntary recalls of Kaboom Action Strips and LiDa DaiDaiHua due to the presence of undeclared active ingredients.
Tamsulosin was found to improve passage of larger, but not smaller, kidney stones compared to placebo, according to a study in the Annals of Emergency Medicine.
Phosphates artificially added to foods like dairy and cereal products have been associated with sharp increases in blood phosphorous levels that could be harmful to the kidneys, particularly for patients with existing reduced kidney function.
Patiromer oral suspension, an investigational drug, was found to reduce elevated potassium levels in patients with chronic diabetic kidney disease in a study published in JAMA.
Testosterone replacement therapy did not improve sexual function males with ejaculatory disorders and low testosterone levels, data from a new study showed.
The PeriCoach System is now available to strength and tone pelvic muscles in women with urinary incontinence following its approval in March 2015.
Patients taking medications for erectile dysfunction may have an increased risk of melanoma, but these drugs are not a cause of melanoma, researchers concluded.
A women's low resting heart rate variability may be associated with sexual dysfunction, a study published in Applied Psychophysiology and Biofeedback has shown.
Men treated for benign prostatic hyperplasia (BPH) with the type II 5 alpha-reductase inhibitor finasteride could be significantly more likely to experience erectile dysfunction (ED) compared to those taking the alpha-1A blocker tamsulosin.
The American Urological Association (AUA) has issued a new list of recommendations as part of the Choosing Wisely campaign.
Vitamin D supplementation could help children with mild-to-moderate chronic kidney disease (CKD) in reducing the risk of renal failure progression, according to a study published in the Journal of the American Society of Nephrology (JASN).
Amgen announced pooled data from two Phase 3 trials evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis.
A new study has shown that treatment for overactive bladder (OAB) may lead to less falls among older adults.
Astellas Pharma announced results from the Phase 3b BESIDE trial with solifenacin (SOLI) with mirabegron (MIRA) as an add-on therapy in incontinent overactive bladder (OAB) patients.
Endo announced that the Food and Drug Administration (FDA) has approved a label update for Xiaflex (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord.
Dexamethasone can help prevent serious kidney complications that can arise following heart surgery, a new study has shown.
The Food and Drug Administration (FDA) is warning consumers not to use or buy the following tainted supplements marketed for weight loss and sexual enhancement:
A high-dose treatment of sodium nitrite and citric acid creams applied twice daily was more effective than placebo for treating anogenital warts, according to a new study in JAMA Dermatology.
The Food and Drug Administration (FDA) has granted Fast Track designation to CRLX101 (Cerulean Pharma) in combination with Avastin (bevacizumab) for the treatment of metastatic renal cell carcinoma (mRCC) following progression through two or three prior lines of therapy.
The Food and Drug Administration (FDA) is warning consumers to not buy or use Extreme Diamond 3000, a product promoted and sold for sexual enhancement.
The FDA is alerting healthcare providers and the public that counterfeit Botox (onabotulinumtoxin A; Allergan) has been found in the United States and may have been distributed to doctors' offices and clinics.
Astellas Pharma and Medivation announced topline results from the Phase 2 STRIVE trial comparing enzalutamide with bicalutamide in men with non-metastatic or metastatic castration-resistant prostate cancer.
The Food and Drug Administration (FDA) has approved a label update for Zytiga (abiraterone acetate; Janssen Biotech) to include statistically significant results in combination with prednisone for the treatment of chemotherapy-naive men with metastatic castration-resistant prostate cancer (mCRPC).
The Food and Drug Administration (FDA) is warning consumers to not buy or use Diablos Eca Fire Caps, Stiff Nights, La Pepa Negra, and Herb Viagra, which are marketed for sexual enhancement.
Encouraging more boys to be vaccinated against human papillomavirus (HPV) may protect more people for the same cost, a recent study reports.
Nonsteroidal anti-inflammatory drugs (NSAIDs) have shown promise in preventing certain types of cancers, but their use can also carry an increased risk of gastric ulcers and potentially life-threatening bleeds. However, a new study suggests that combining a proton pump inhibitor with an NSAID could reduce the risk of bladder cancer by as much as 75 percent.
Hypertension, taking multiple medications and working a physically demanding job may impact male fertility, according to researchers at the National Institutes of Health (NIH) and Stanford University
The Food and Drug Administration (FDA) has authorized use of Lixelle Beta 2-microglobulin Apheresis Column (Kaneka Pharma America), the first device to treat dialysis-related amyloidosis (DRA).
The Food and Drug Administration (FDA) is warning consumers to not buy or use Black Ant King, Black Mamba Premium, African Superman, and Bigger Longer More Time More Sperms (sic), which are all marketed for sexual enhancement.
Men presenting with erectile dysfunction (ED) may benefit from screening for cardiovascular disease (CVD), a new cost-analysis study shows.
The Food and Drug Administration (FDA) announced that prescription testosterone product labels must be changed to clarify the approved use of these medications and information on the possible increased risk of heart attacks and strokes in patients taking testosterone must also be added.
A new report predicts that the prevalence of chronic kidney disease (CKD) in adults aged 30 and over will rise from the current rate of 13.2 percent to 16.7 percent by 2030.
The Food and Drug Administration (FDA) is warning consumers to not use or buy SEx Men, Super Hard, Santi Scalper, Vigra, Plant Vigra, Vigour 300, MME MAXMAN, Hard Wang, FX3000 after they were found to contain hidden drug ingredients.
Researchers from the University of Buffalo have found a way to improve remyelination for myelin-based diseases like multiple sclerosis (MS).
Many of the tests performed to screen for chronic kidney disease (CKD) may offer little clinical benefit on diagnosis and management, according to a research letter.
The Food and Drug Administration (FDA) has warned against the use of Libigrow XXX Treme, Night Man, Black King Kong, 72HP, Tibet Babao, and Germany Niubian supplements promoted for sexual enhancement.
Upsher-Smith announced that Vogelxo (testosterone) gel 1% has received an AB (therapeutic equivalent) rating from the Food and Drug Administration (FDA).
Rockwell Medical announced that the FDA has approved Triferic (soluble ferric pyrophosphate) as an iron replacement product to maintain hemoglobin in adults with hemodialysis dependent chronic kidney disease.
The Food and Drug Administration (FDA) is warning healthcare professionals and consumers that counterfeit versions of Cialis (tadalafil; Eli Lilly) 20mg tablets were discovered in the mail in transit to a U.S. consumer.
The Food and Drug Administration (FDA) is advising consumers to not buy or use Happy Passengers, a product promoted and sold for sexual enhancement.
Baxter announced that the Food and Drug Administration (FDA) has approved Phoxillum Renal Replacement Solutions (BK4/2.5 and B2K4/0) for use in continuous renal replacement therapy (CRRT) to replace plasma volume removed by ultrafiltration, correct electrolyte and acid-base imbalances, and for use in drug poisoning when CRRT is used to remove dialyzable substances.
Brown adipose tissue was successfully activated and energy expenditure increased in 12 lean adult men treated with mirabegron in a new study.
The Food and Drug Administration (FDA) has granted orphan drug designation for Retrophin's sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS).
The Centers for Disease Control and Prevention (CDC) has released its annual fact sheet of the three reported sexually transmitted diseases (STDs): chlamydia, gonorrhea, and syphilis.
The Food and Drug Administration (FDA) has granted the first-ever waiver under specific laboratory regulation for Syphilis Health Check test to be used in expanded healthcare settings.
Ortho-Clinical Diagnostics announced the launch of NephroCheck Test System to help identify patients at risk of developing moderate or severe acute kidney injury (AKI) within 12 hours of assessment.
The Food and Drug Administration (FDA) has approved Gardasil 9 (9-valent human papillomavirus types, recombinant; Merck) vaccine for the prevention of cervical, vulvar, vaginal, anal cancers, and for the prevention of genital warts caused by nine types of human papillomavirus (HPV).
InControl Medical announced it has received clearance from the Food and Drug Administration (FDA) to market their Apex Device over-the-counter (OTC).
Hospital-acquired conditions (HACs) experienced a 17% decline from 2010-2013 and a 9% reduction from 2012-2013, according to figures released by the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS).
In patients with autosomal dominant polycystic kidney disease (ADPKD), the use of two drugs was not more effective than using a single drug in slowing disease progression, according to the results of two studies funded by the National Institutes of Health (NIH).
Certain chemicals used in sunscreens and other personal care products have been linked to reduced fecundity in men, according to a study appearing in the American Journal of Epidemiology.
ArQule announced positive results from a Phase 2 clinical trial of tivantinib as a single agent in metastatic prostate cancer.
The American College of Emergency Physicians (ACEP) has released a second list of their Choosing Wisely recommendations.
The Food and Drug Administration (FDA) has granted marketing clearance for the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults with impaired detrusor contractility (IDC).
Lipocine announced top-line results from its Phase 3 SOAR clinical trial evaluating the efficacy and safety of LPCN 1021, an oral testosterone agent in hypogonadal men with low testosterone.
Vivus and Auxilium announced that the Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Stendra (avanafil) to be taken ~15 minutes before sexual activity in the treatment of erectile dysfunction.
Astellas and Medivation announced that the Food and Drug Administration has approved a new indication for Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
Vasalgel, the first male contraceptive injection, is anticipated to enter its first clinical trial beginning in 2015, according to the Parsemus Foundation.
The Food and Drug Administration (FDA) announced that it has allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to assist in determining if some critically ill hospitalized patients are at risk of developing moderate-to-severe acute kidney injury (AKI) in the 12 hours post-test.
Baxter announced a voluntary recall of 2 lots of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II).
The Food and Drug Administration (FDA) is advising consumers to not buy or use Arize and Herbal Vigor Quick Fix, products marketed for sexual enhancement.
A multi-specialty team comprised of pathologists, radiation oncologist, surgeons, and urologists published their recommendations for determining prostate cancer active surveillance.
A new study has found that blood pressure (BP) below and above the current Eighth Joint National Committee (JNC 8) recommended targets is linked to an increased risk of renal disease and mortality.
The FDA is warning consumers not to purchase or use O.M.G., a product marketed for sexual enhancement.
The FDA has granted Orphan Drug designation to RG-012 (Regulus), a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 for the treatment of Alport syndrome.
For the first time, the WHO is strongly recommending that men who have sex with men (MSM) consider pre-exposure prophylaxis for the prevention of HIV infection in addition to the use of condoms.
Use of low-molecular-weight heparin decreased the risk of death by 52%.
The FDA announced that it is now requiring a general warning in the drug labeling of all approved testosterone products regarding the risk of venous blood clots unrelated to polycythemia.
The FDA is advising consumers to not purchase or use Gold Vigra, a product marketed and sold for sexual enhancement.
Takeda and Lundbeck announced the results from a new head-to-head study of Brintellix (vortioxetine) compared to escitalopram in patients with well treated MDD experiencing treatment-emergent sexual dysfunction (TESD).
Erectile dysfunction (ED) is present and frequently severe in most men with gout, reports research presented at the European League Against Rheumatism Annual Congress (EULAR 2014).
Women with hematuria were less than half as likely as men with the same issue to be referred to a urologist for further tests, according to a new study.
The FDA is warning consumers to not buy or use Zhen Gong Fu, a product promoted for sexual enhancement.
The FDA is warning consumers that several products promoted and sold for sexual enhancement have been found to contain undeclared ingredients and should not be purchased or used.
The FDA has allowed marketing of the EUROIMMUN Anti- PLA2R IFA blood test, the first non-invasive test to help determine if membranous glomerulonephritis (MGN) is autoimmune or if it is due to another cause (eg, infection).
Sanofi and Eli Lilly and Company have announced an agreement to pursue FDA approval of Cialis (tadalafil; Eli Lilly and Company) as an over-the-counter treatment for erectile dysfunction (ED).
InControl Medical announced that the FDA has cleared InToneMV, a non-surgical, implant-free treatment for male patients with urinary or fecal incontinence.
A new study has found that 69% percent of healthy American adults are infected with one or more of 109 strains of the human papillomavirus (HPV).
Auxilium Pharmaceuticals announced new data from its Phase 3 IMPRESS trials that evaluated Xiaflex for the treatment of Peyronie's disease at the 2014 Annual Meeting of the AUA.
Data from 2 studies evaluating sexual function in men with lower urinary tract symptoms as well as post bilateral nerve-sparing radical prostatectomy was presented at the 2014 Annual Scientific Meeting of the AUA.
The FDA is advising consumers not to purchase or use MV5 Days, a product marketed for sexual enhancement.
Proteon Therapeutics announced results from a Phase 2 clinical trial of PRT-201 to use to prolong the patency and reduce the failure of hemodialysis vascular access in patients with chronic kidney disease (CKD).
GenomeDx Biosciences announced data from two studies showing that Decipher Prostate Cancer Classifier significantly altered treatment decisions and increased confidence in treatment decision-making for men considering adjuvant therapy following prostate surgery.
The FDA has accepted for filing a sNDA to extend the indication for Xtandi (enzalutamide; Astellas Pharma and Medivation) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.
Acceleron and Celgene announced interim data from the Phase 2a study of sotatercept (ACE-011), demonstrating dose dependent increases in hemoglobin in patients with end stage renal disease (ESRD) on hemodialysis.
Beckman Coulter Diagnostics announced the launch of Prostate Health Index (phi), a non-invasive blood test for detecting prostate cancer.
Many lung cancer patients experience difficulties with sexual expression and intimacy, a topic that has long been ignored by doctors and researchers.
Questcor Pharmaceuticals announced results from an investigator-initiated clinical study evaluating the dosing and effectiveness of H.P. Acthar Gel (repository corticotrophin injection) in 20 patients with nephrotic syndrome due to idiopathic membranous nephropathy (iMN).
The FDA has warned consumers that the sexual enhancement supplement S.W.A.G. contains an undisclosed ingredient and should not be purchased or used.
Nova Products announced a voluntary recall of African Black Ant, Black Ant, XZen Gold, ZXen Platinum, XZen 1200, XZone Gold, and XZone 1200, products marketed as dietary supplements for sexual enhancement.
Researchers have coaxed human stem cells into becoming bladder cells that could aid in repairing defective or diseased bladders.
Prostate-specific antigen screening has decreased since publication of the U.S. Preventive Services Task Force Recommendations against screening
Resolved childhood glomerular disease is associated with increased subsequent risk of hypertension.
For patients with prostate cancer, stereotactic body radiation therapy is less expensive than intensity-modulated radiation therapy, but is associated with more genitourinary toxicity.
For women undergoing surgery for vaginal prolapse and stress urinary incontinence, outcomes for two common transvaginal approaches are comparable, and perioperative behavioral therapy with pelvic floor muscle training does not improve surgical outcomes
Over the last 25 years, pediatric kidney transplantation outcomes have improved in the United States.
The FDA has warned consumers that the sexual enhancement supplement Weekend Warrior contains an undisclosed ingredient and should not be purchased or used.