Natroba (Spinosad) Head Lice Treatment for Children and Adults - FDA Approval
The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older.
View ArticleFDA Approves Viibryd to Treat Major Depressive Disorder
The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.
View ArticleNeuralstem Receives FDA Orphan Designation for Spinal Cord Stem Cells for...
Neuralstem, Inc. announced that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted it orphan drug designation for the treatment of Amyotrophic Lateral Sclerosis...
View ArticleEdarbi for High Blood Pressure Approved by FDA
The U.S. Food and Drug Administration today approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.
View ArticleZostavax Vaccine to Prevent Shingles - FDA Approval
FDA Approves Zostavax Vaccine to Prevent Shingles in Individuals 50 to 59 Years of Age.
View ArticleTreatment for a Late Stage Skin Cancer
The U.S. Food and Drug Administration today approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.
View ArticleFDA Proposes Draft Menu and Vending Machine Labeling Requirements
The U.S. Food and Drug Administration today issued two proposed regulations regarding calorie labeling on menus and menu boards in chain restaurants, retail food establishments, and vending machines.
View ArticleHorizant for Restless Legs Syndrome FDA Approved
On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets (gabapentin enacarbil), a once-daily treatment for moderate-to-severe restless legs syndrome (RLS).
View ArticleFDA Approves Tradjenta(TM) (linagliptin) for Treatment of Type 2 Diabetes
First DPP4 inhibitor approved at one dosage strength; no dose adjustment recommended for patients with type 2 diabetes who have kidney or liver impairment.
View ArticleFDA Approves Victrelis for Hepatitis C
The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients.
View ArticleEdurant a New HIV Treatment Approved by FDA
The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy...
View ArticleQ Fever Test for Military Personnel Serving Overseas
The U.S. Food and Drug Administration today cleared the first nucleic acid amplification test to diagnose the early stages of Q fever infections in military personnel serving overseas.
View ArticleSutent for Rare Type of Pancreatic Cancer Approved by FDA
The U.S. Food and Drug Administration has approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or...
View ArticleToxoplasmosis Parasite Infection Test
FDA clears first test for recent infection with toxoplasmosis parasite.
View ArticleInjectable Gel to Treat Fecal Incontinence Approved by FDA
The U.S. Food and Drug Administration today approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility...
View ArticleGlobal Strategy to Help Ensure Safety and Quality of Imported Products
FDA Unveils New Global Strategy to Help Ensure Safety and Quality of Imported Products - Strategy calls for coalitions of international regulators, increased data sharing.
View ArticleFDA Approves Lazanda (Fentanyl) Nasal Spray for Breakthrough Cancer Pain
On Average, More than Half of Patients with Cancer Experience Debilitating Breakthrough Pain.
View ArticleBoostrix for Tetanus, Diphtheria and Pertussis in Seniors
FDA Approves Boostrix to Prevent Tetanus, Diphtheria, and Pertussis in Older People.
View ArticleCialis to Treat Benign Prostatic Hyperplasia Approved by FDA
The U.S. Food and Drug Administration approves Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and...
View ArticleInsomnia Drug Intermezzo Approved by FDA
FDA Approves First Insomnia Drug for Middle-of-the-Night Waking Followed By Difficulty Returning to Sleep.
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