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FDA Committee Favors Peginesatide

December 15, 2011

The FDA's Oncologic Drugs Advisory Committee, in a 15 to 1 vote, has agreed that peginesatide demonstrates a favorable benefit/risk profile for use in treatment of dialysis patients with anemia resulting from chronic kidney disease (CKD).
 

Long-Acting Drug for Post-Op Pain Approved

November 01, 2011

The FDA has approved Exparel (bupivacaine), a single-dose injection that provides post-surgical pain relief for up to 72 hours.
 

Drug Cleared for Treating ADT-Related Bone Loss in Prostate Cancer Patients

September 19, 2011

The FDA has approved denosumab (Prolia) as a treatment to increase bone mass in prostate cancer patients at high risk for fracture undergoing androgen deprivation therapy (ADT) and women with breast cancer at high risk for fracture who are receiving aromatase inhibitor therapy.
 

FDA Issues Surgical Mesh Safety Alert

August 01, 2011

The FDA recently issued a safety alert regarding placement of surgical mesh as a treatment for pelvic organ prolapse (POP).
 

New Indication Okayed for Chronic Hepatitis B Drug

November 16, 2010

Bristol-Myers Squibb of Princeton, N.J., has received FDA approval to market Baraclude (entecavir) as a treatment for chronic hepatitis B (CHB) patients with evidence of decompensated liver disease.
 

New Oral Anticoagulant Cleared for Reducing Stroke Risk

November 16, 2010

Pradaxa (dabigatran etexilate) capsules have received FDA approval for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib).
 

FDA Takes On Unapproved Single-Ingredient Colchicine

November 16, 2010

The FDA has ordered a halt to the marketing of unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of familial Mediterranean fever.
 

Brand Name for Epoprostenol for Injection Okayed

October 29, 2010

The FDA has approved the brand name for commercially available Veletri (epoprostenol for injection) for pulmonary arterial hypertension (PAH).
 

Withdrawal of Approval for Midodrine Proposed

October 29, 2010

The FDA has proposed withdrawing approval of midodrine, a drug used to treat orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the medication have not been done, the agency announced.
 

Drug for Chronic Refractory Gout Approved

October 29, 2010

Savient Pharmaceuticals, Inc., of East Brunswick, N.J., has received FDA clearance to market Krystexxa (pegloticase) as a treatment for chronic gout in adult patients refractory to conventional treatment.
 

Ultra-Fine Pen Needle for Diabetics Debuts

July 27, 2010

Becton, Dickinson and Company (BD), based in Franklin Lakes, N.J., has launched the BD Ultrafine Nano, which the company says is the world's smallest pen needle.
 

Over the Counter Pain Relief Patches Introduced

July 27, 2010

Hisamitsu Pharmaceutical, which has U.S. headquarters in Torrance, Calif., has introduced two over-the-counter pain relief patches to the American market, the Salonpas Pain Relief Patch and Salonpas Arthritis Pain patch.
 

Marketing Clearance Granted to New Glucose Test Strips

July 27, 2010

Abbott has received FDA clearance to market FreeStyle Lite glucose test strips. The test strips minimize interference during blood glucose testing and are designed to offer a better experience, Abbott says.
 

Imaging Agent for Bladder Cancer Okayed

July 27, 2010

The FDA has approved Cysview (hexaminolevulinate HCl), an optical imaging agent indicated for use in the cystoscopic detection of non-muscle-invasive papillary bladder cancer in patients suspected or known to have lesions on the basis of prior cystoscopy.
 

FDA Mulls Application for Prostate Imaging Device

July 27, 2010

ProUroCare Medical, Inc., of Minneapolis, Minn., has filed a de novo application with the FDA seeking marketing clearance for its prostate mechanical imaging (PMI) device (ProUroScan).
 

Intranasal Ketorolac Cleared for Pain Management

June 14, 2010

A novel prescription intranasal formulation of ketorolac tromehtamine (Sprix Nasal Spray), a non-steroidal anti-inflammatory drug, has been approved for the short-term management of acute moderate to moderately severe pain that requires analgesia at the opioid level.
 

GnRH Agonist Safety Is Under Review

June 14, 2010

The FDA is conducting a safety review of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs used primarily as a treatment for prostate cancer.
 

Home Hemodialysis Safety Device Approved

June 14, 2010

The Redsense safety device, which is designed to detect venous needle displacement during hemodialysis (HD), has received FDA approval for home/self use during home HD, according to the device's manufacturer, Redsense Medical.
 

Company Introduces Its Novel Male Sling for SUI

June 14, 2010

San Francisco-based Coloplast has announced the debut of a new sling for treating male stress urinary incontinence (SUI).
 

Lower Dosage Strength Sirolimus Tablets Available

June 14, 2010

A lower dosage strength sirolimus (Rapamune) tablet is now commercially available, according to the drug's maker, Pfizer Inc., of New York.
 

New Device May Facilitate Kidney Cancer Diagnosis

June 14, 2010

Cook Medical, of Bloomington, Ind., has introduced BIGopsy Backloading Biopsy Forceps, a device that has a 4 mm3 biopsy cup to obtain large renal or ureteral tissue specimens for cancer diagnosis.
 

Boston Scientific, Bladder Health Network Enter Pact

May 21, 2010

Boston Scientific Corp., of Natick, Mass., has entered into a four-year exclusive marketing agreement with Bladder Health Network (BHN), a privately held company headquartered in Jackson, Miss., that offers advanced testing solutions for urinary incontinence.
 

New Formulation of PAH Medication Is Now Available

May 21, 2010

Epoprostenol for Injection, an improved formulation of epoprostenol that is stable at room temperature, is now commercially available, according to the drug's maker, Actelion Pharmaceuticals US, Inc., of South San Francisco, Calif.
 

Data Support PCa Vaccine's Mechanism of Action

May 21, 2010

Phase 3 trial data presented at the American Association of Cancer Research annual meeting support the mechanism of action of Provenge (sipuleucel-T), a novel investigative immunotherapy for advanced prostate cancer, according to a statement issued by Dendreon Corp., of Seattle, which is developing the treatment.
 

Buccal Tablets for Oropharyngeal Candidiasis Cleared

May 21, 2010

The FDA has approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis in adults and childen aged 16 years and older.
 

High-Resolution Camera for Medical Imaging Approved

May 21, 2010

Toronto-based hybridyne Imaging Technologies has received FDA clearance for ProxiScan, a high-resolution gamma camera for detecting cancer and other abnormalities.
 

FDA Is Examining the Safety of GnRH Agonists

May 04, 2010

Preliminary review suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with the medications.
 

Novel, Coated Hemodialysis Catheter Enters Market

April 27, 2010

A Maple Grove, Minn., company has launched a new long-term hemodialysis catheter with a coating it says will decrease thrombus accumulation.
 

A More Flexible Needle for SUI Procedures Unveiled

April 27, 2010

Uroplasty, Inc., based in Minnetonka, Minn., has introduced a newly designed endoscopic injection needle that can be used in conjunction with the system used to inject Macroplastique.
 

First Generic Tamsulosin Okayed for Treating BPH

April 27, 2010

The FDA has approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH).
 

Abbott Seeks FDA Approval for Six-Month Lupron Depot

April 27, 2010

The FDA is reviewing Abbott's supplemental New Drug Application for a new six-month 45-mg formulation of Lupron Depot (leuprolide acetate for depot suspension) for the palliative treatment of advanced prostate cancer.
 

FDA Clears a Six-Month Trelstar Formulation

April 27, 2010

Watson Pharmaceuticals has received FDA approval of Trelstar (triptorelin pamoate for injectable suspension) 22.5 mg, the first and only six-month intramuscular gonadotropin releasing hormone (GnRH) agonist for the palliative treatment of advanced prostate cancer.
 

New Device for Endoscopic VUR Treatment Introduced

April 27, 2010

A new injection device for the endoscopic treatment of vesicoureteral reflux (VUR) is designed to give urologists greater control and precision in VUR repair, according to the device's maker, Cook Medical, of Bloomington, Ind.
 

Everolimus Okayed for Preventing Renal Transplant Rejection

April 22, 2010

Novartis Pharmaceuticals, based in East Hanover, NJ, has received FDA approval of Zortress (everolimus) oral tablets for preventing rejection of kidney transplants in adult patients at low-to-moderate immunologic risk.
 

Safety Plan Announced for Agents Used to Treat Chemo-Related Anemia

March 30, 2010

The FDA has approved a risk management program to inform health care providers and their patients about the risks of erythropoiesis-stimulating agents (ESAs), which include epoetin alfa and darbepoetin alfa.
 

Pneumococcal Vaccine with Broader Protection Cleared

March 30, 2010

The FDA has approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and children aged six weeks through five years.
 

Olmesartan Cleared for Treating Hypertension in Children

March 30, 2010

The FDA approved the use of Benicar (olmesartan medoxomil) for the treatment of hypertension in individuals aged 6 to 16 years. The drug original was cleared in 2002 for the treatment of adult hypertension.
 

New Indication Approved for Rosuvastatin

March 30, 2010

Crestor (rosuvastatin calcium) has received FDA approval to market the drug as a treatment for reducing the risk of stroke, myocardial infarction (MI), and arterial revascularization.
 

Company Grants License to Its Diabetes Biomarkers

March 02, 2010

Intrinsic Bioprobes, of Tempe, Ariz.,a privately held biotechnology company, has licensed two novel biomarkers for diabetes to Ortho-Clinical Diagnostics, Inc., of Raritan, N.J.
 

Gambro Acquires Medical Device Company

March 02, 2010

Gambro, which has its U.S. headquarters in Lakewood, Colo., has acquired CHF Solutions, a privately held medical device company in Brooklyn Park, Minn., that manufactures and distributes ultrafiltration devices to treat fluid overload, both companies announced recently.
 

Fresenius Buys the Company That Sells Acumen nEHR

March 02, 2010

Fresenius Medical Care North America (FMCNA), headquartered in Waltham, Mass., has acquired Nashville-based Health IT Services Group and its portfolio of products, including Acumen nEHR, a nephrology-specific electronic health record.
 

Drug Cleared for Treating Moderate to Severe Rheumatoid Arthritis

March 02, 2010

Roche has received marketing clearance for Actemra (tocilizumab) as a treatment for moderate to severe active rheumatoid arthritis (RA) in adults who have had an inadequate response to one or more treatments that block tumor necrosis factor.
 

FDA Warns Consumers about Counterfeit Weight-Loss Product

March 02, 2010

The FDA has issued a warning to consumers about a counterfeit and possibly harmful version of Alli 60 mg capsules (120 count refill kit). Alli is an over-the-counter weight-loss product.
 

Wyeth Makes Drug Monitoring Changes for Sirolimus

March 02, 2010

Wyeth has notified health care professionals of changes to the Rapamune (sirolimus) prescribing information related to changes in the performance of an immunoassay used for therapeutic drug monitoring (TDM) of the medication, according to the FDA.
 

Institute Is Awarded DoD Grant For Prostate Cancer Drug Research

November 19, 2009

The U.S. Department of Defense/Prostate Cancer Research Program (DoD/PCRP) has awarded a $1.55 million grant to SRI International, a nonprofit research institute based in Menlo Park, Calif., to support product-driven, preclinical studies of novel agents that have the potential to become prostate cancer drugs.
 

Lithostat for Struvite Stones Reintroduced

November 19, 2009

Lithostat (acetohydroxamic acid), the only urease inhibitor available for urea-splitting urinary infections in association with struvite stones, is available again at pharmacies nationwide, according to the drug's marketer, Mission Pharmacal.
 

Telmisartan Okayed for Cardiovascular Risk Reduction

November 19, 2009

Boehringer Ingelheim Pharmaceuticals has received approval for a new indication for its angiotensin II receptor blocker Micardis (telmisartan).
 

Colchicine Formulation Cleared for Preventing Gout Flares

November 19, 2009

Colcrys, a new colchicine formulation, has received marketing clearance for the prevention of gout flares.
 

New Medication Approved for Treated Advanced Renal Cell Carcinoma

November 19, 2009

The FDA has approved Votrient (pazopanib) for the treatment of advanced renal cell carcinomia (RCC).
 

Valrubicin Is Reintroduced for the Treatment of CIS

October 16, 2009

Endo Pharmaceuticals, of Chadds Ford, Pa., has reintroduced Valstar (valrubicin) for the treatment of carcinoma in situ (CIS) of the urinary bladder that is refractory to treatment with Bacillus-Calmette-Guérin (BCG).
 

Patent is Filed for Device To Ease Catheter Insertion

October 16, 2009

Urovalve, of Newark, N.J., has filed a patent for a device that facilitates insertion of catheters, such as Foley catheters, the company said.
 

Anti-CMV Drug Cleared for Pediatric Transplant Patients

October 16, 2009

The FDA has approved Valcyte (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant recipients (aged four months to 16 years) who are at high risk of developing the disease.
 

Orally Dissolving Tablets for Diabetic Gastroparesis Cleared

October 16, 2009

Salix Pharmaceuticals has receiving marketing clearance for Metozolv (metoclopramide HCl) ODT (orally dissolving tablets) 5 mg and 10 mg orally disintegrating tablets for the relief of diabetic gastroparesis and symptomatic documented gastroesophageal reflux (GERD).
 

FDA Approves Aliskiren/Valsartan Combination Pill

October 16, 2009

FDA has approved Valturna (aliskiren and valsartan) tablets, which the drug's maker, Novartis, of East Hanover, N.J., said is the first and only product to target two key points in the renin angiotensin aldosterone system (RAAS).
 

Fentanyl Patch Lot Is Recalled

September 17, 2009

Watson Pharmaceuticals is voluntarily recalling one lot of 100 mcg/hr Fentanyl Transdermal System patches sold in the United States, according to a company press release.
 

NJ Hospitals To Test System of Incentives

September 17, 2009

A dozen hospitals in New Jersey and their affiliated physicians are participating in the Physician Hospital Collaboration Demonstration, a Medicare project to evaluate a program aimed at reducing health-care costs and improving quality of care.
 

Light-Activated Drug for BPH Enters Phase 2 Clinical Trial

September 17, 2009

Researchers recently treated the first patients who are participating in a phase 2 clinical trial of a novel therapy for benign prostatic hyperplasia (BPH).
 

Aliskiren-HCTZ Combo Okayed as First-Line Therapy

September 17, 2009

Tekturna HCT, a single-pill combination of aliskiren—the first and only approved direct renin inhibitor—and hydrochlorothiazide (HCTZ) has been approved as initial therapy for patients who are likely to need multiple drugs to achieve their BP.
 

Treatment for Pulmonary Arterial Hypertension Cleared

September 17, 2009

The FDA has cleared Tyvaso (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH).
 

Drug Cleared for Use in Treating Metastatic RCC

September 17, 2009

The FDA has approved Avastin (bevacizumab) plus interferon-alfa as a treatment for metastatic renal cell carcinoma (RCC).
 

Degarelix Gets a Trade Name: Firmagon

September 17, 2009

FDA has approved the trade name Firmagon for degarelix for injection, a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of advanced prostate cancer.
 

Device To Help Diagnose Bladder Problems Debuts

August 19, 2009

Verathon has introduced the BladderScan BVM 9500 bladder volume instrument.
 

Patent Issued for OAB Neuromodulation System

August 19, 2009

Uroplasty, Inc., a medical device company with headquarters in Minnetonka, Minn., has received a patent for its Urgent PC Neuromodulation System and stimulation methods for treating overactive bladder (OAB).
 

NDA Filed for Mixed Dyslipidemia Treatment

August 19, 2009

Abbott (Abbott Park, Ill.) and AstraZeneca (London, UK) have submitted a New Drug Application (NDA) for an investigational drug to treat mixed dyslipidemia. Pending approval of the NDA, the drug will be marketed as Certriad.
 

NDA Accepted for Once-Weekly Injectable Diabetes Drug

August 19, 2009

The FDA has accepted a New Drug Application (NDA) for exenatide once weekly.
 

Ferumoxytol Approved to Treat Iron Deficiency Anemia in CKD Patients

August 19, 2009

AMAG Pharmaceuticals, of Lexington, Mass., has received marketing clearance for Feraheme (ferumoxytol) Injection as a treatment for iron deficiency anemia in adult CKD patients.
 

FDA: Penile Implant Reduces Infection Risk

August 19, 2009

American Medical Systems' AMS 700 with InhibiZone—a proprietary combination of antibiotics—has received FDA's okay to be marketed as the only inflatable penile prosthesis with clinical evidence showing a significant decrease in the need for revision surgery because of infection.
 

Tacrolimus Cleared for Use with MMF in Renal Transplant Patients

July 23, 2009

Astellas Pharma US, in Deerfield, Ill., has received approval for the use of Prograf (tacrolimus) in conjunction with mycophenolate mofetil (MMF) in kidney transplant recipients.
 

First and Only Topical Gel for Overactive Bladder Cleared

July 23, 2009

Watson Pharmaceuticals, Corona, Calif., has received approval for Gelnique (oxybutynin chloride) Gel 10%, the first and only topical gel for the treatment of overactive bladder (OAB).
 

Hyponatremia Drug Receives Marketing Clearance

July 23, 2009

The FDA has approved Samsca tablets (tolvaptan) to treat hyponatremia, one of the most common electrolyte disorders seen in hospitalized patients.
 

Panel Recommends Approval of Drug for Refractory Gout

July 23, 2009

The FDA's Arthritis Drugs Advisory Committee has recommended that Krystexxa (pegloticase) be approved for treating refractory chronic gout.
 

Cook Medical to Market Pneumatic Lithotripter

July 23, 2009

As a result of a partnership with LMA Urology, of Gland, Switzerland, Cook Medical, of Bloomington, Ind., has added a new lithotripter to its kidney stone treatment line.
 

BPH Medication to Be Tested in an Extended Phase 3 Study

July 23, 2009

Æterna Zentaris Inc., of Quebec City, Canada, has announced the opening of an extended phase 3 study of cetrorelix, a treatment for benign prostatic hyperplasia (BPH).
 

Probiotic for Dietary Supplement for Kidney Health Introduced

May 05, 2009

Kibow Biotech, Inc., of Newtown Square, Pa., has launched Kibow Biotics, a scientifically formulated and clinically tested dietary supplement that helps maintain healthy kidney function.
 

Premixed Hyponatremia Drug Now Commercially Available

May 05, 2009

Astellas Pharma US, Inc., of Deerfield, Ill., has announced the commercial availability of conivaptan hydrochloride injection (Vaprisol) premixed in 5% dextrose.
 

FDA Warns About Wearing Medicated Patches During MRIs

May 05, 2009

The FDA has issued a Public Health Advisory about the potential for burns if transdermal drug patches are worn during MRI scanning.
 

Cardiovascular Risk Profile of Diabetes Drug Acceptable

May 05, 2009

Onglyza (saxagliptin), an investigational diabetes drug under joint development by Bristol-Myers Squibb and AstraZeneca, has a cardiovascular risk profile acceptable to the FDA's Endocrinology and Metabolic Drugs Advisory Committee, according to a press release issued by the companies.
 

Phase 3 Trial of Bladder Cancer Drug Completes Recruitment

May 05, 2009

Under the FDA's Accelerated Approval program, Bioniche Life Sciences, Inc., has completed phase 3 recruitment registration for its agent Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory to BCG.
 

Drug for Advanced Kidney Cancer Approved

May 05, 2009

The FDA has approved Afinitor (everolimus) oral tablets for the treatment of advanced kidney cancer that has progressed after treatment with other cancer therapies.
 

New Drug Cleared For Gout Patients

March 06, 2009

A new oral medication that reduces serum uric acid levels has received FDA approval for treating hyperuricemia in patients with gout.
 

Analgesic Okayed for Relief of Chronic Pain

March 06, 2009

Labopharm Inc., of Laval, Québec, Canada, has announced that it has received approval for Ryzolt (tramadol HCl extended-release tablets) in a once-daily formulation.
 

Safety Review on Cholesterol-Lowering Drugs Updated

March 06, 2009

The FDA has reaffirmed its position that elevated LDL is a risk factor for heart attack, stroke, and sudden death, among other cardiovascular diseases, and that reducing LDL levels lowers the risk of these diseases.
 

IND Application for Conjugate to Fight RCC Advances

March 06, 2009

The FDA has accepted an investigational new drug (IND) application from Medarex, Inc., for MDX-1203, the company's first antibody-drug conjugate (ADC). The ADC is made of a potent cytotoxic prodrug chemically linked with an anti-CD70 antibody.
 

Blood Glucose Monitoring System Approved

March 06, 2009

The Glucocard 01-mini Blood Glucose Monitoring System from Arkray USA, Inc., of Minneapolis, the only such system that features interchangeable faceplates so users can personalize the look of their monitor, has received marketing clearance.
 

Topical Gel for Overactive Bladder Approved

March 06, 2009

Gelnique (oxybutynin chloride) Gel 10%, the first and only topical gel for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, has received FDA approval.
 

New Data Needed on Anemia Drug for CKD Patients

February 10, 2009

AMAG Pharmaceuticals, Inc., of Lexington, Mass., has received a Complete Response letter from the FDA regarding ferumoxytol for the treatment of iron deficiency anemia (IDA) in CKD patients.
 

Fibrate Cleared to Manage Cholesterol in Combo with Statin

February 10, 2009

Abbott Laboratories, in Abbott Park, Ill., has received approval of Trilipix (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL and raise HDL in patients with lipid problems.
 

New Recommendations on Evaluating CV Risk of Diabetes Drugs

February 10, 2009

The FDA has announced new recommendations on evaluating cardiovascular (CV) risk of drugs intended to treat type 2 diabetes, asking manufacturers to provide evidence that the therapy will not increase the risk of heart attacks and other events.
 

Injectable Drug for Advanced PCa Approved

February 10, 2009

Degarelix, an injectable treatment for advanced prostate cancer manufactured for Ferring Pharmaceuticals Inc., Parsippany, N.J., by Rentschler Biotechnologie Gmbh, Laupheim, Germany, has won approval from the FDA.
 

FDA Takes Action on Some Bowel Preps

February 04, 2009

The FDA is recommending that only prescription oral sodium phosphate (OSP) bowel preparations be used by patients for bowel cleansing prior to undergoing colonoscopy. The agency also is requiring "black box" warnings on these products.
 

Analgesic for Acute Pain Okayed

January 22, 2009

The FDA has approved tapentadol hydrochloride, an immediate-release oral tablet in doses of 50, 75, or 100 mg for the relief of moderate-to-severe acute pain.
 

New Data Required on Drug for Diabetic Foot Infections

January 22, 2009

Johnson & Johnson Pharmaceutical Research & Development, LLC, has received a Complete Response letter regarding its New Drug Application for ceftobiprole medocaril to treat complicated skin and skin structure infections, including diabetic foot infections.
 

NDA Accepted for Six-Month Prostate Cancer Treatment

January 22, 2009

The New Drug Application (NDA) by Watson Pharmaceuticals, Inc., for a six-month formulation of Trelstar (triptorelin pamoate) has been accepted for filing.
 

Trial for Fluid Replacement System and CIN Prevention

January 22, 2009

PLC Medical Systems, Inc., of Franklin, Mass., has received full approval for a U.S. pivotal trial to study the effectiveness of its RenalGuard System and associated therapy in the prevention of contrast-induced nephropathy (CIN).
 

TRT System Now Indicated for AKI Patients

January 22, 2009

FlowMedica, Inc., of Fremont, Calif., announced that it has received clearance for a new labeling indication for its Benephit Infusion Systems, which can now facilitate targeted renal therapy (TRT) in patients who have demonstrated symptoms of or are at risk of developing acute kidney injury (AKI).
 

New Daily Tablet to Treat OAB Approved

December 22, 2008

Toviaz (fesoterodine fumarate), manufactured by Schwarz Pharma of Zwickau, Germany, and distributed by Pfizer, has been approved to help patients suffering from overactive bladder (OAB).
 

Alert Issued on Surgical Mesh for Pelvic Organ Prolapse and SUI

December 22, 2008

The FDA has issued an alert to health-care professionals and the public after receiving reports of complications from the use of surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
 

Insulin Glulisine for Pediatric Diabetes Cleared

December 22, 2008

Sanofi-aventis has received approval for Apidra (insulin glulisine [rDNA origin] injection) to improve glycemic control in children aged four years and older with diabetes mellitus.
 

Pre-Mixed Drug for Hyponatremia Okayed

December 22, 2008

Vaprisol (conivaptan hydrochloride injection) Premixed in 5% Dextrose, a new formulation of Vaprisol developed by Astellas Pharma US, Inc., has been approved for the treatment of both euvolemic and hypervolemic hyponatremia in hospitalized patients.
 

No Link Found Between Statins and ALS Risk

November 01, 2008

An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), the neurodegenerative disorder commonly called "Lou Gehrig's disease."
 
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