New campaign seeks to remove opioids from the home
The Food and Drug Administration is looking to women aged 35-64 to “Remove the Risk” of opioids in the household.
Latest News
U.S. FOOD AND DRUG ADMINISTRATION: First FDA-approved vaccine for the prevention of dengue disease in endemic regions
The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves device to help increase access to more lungs for transplant
The U.S. Food and Drug Administration approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for pediatric patients with lupus
The U.S. Food and Drug Administration approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) – often referred to as simply “lupus”
NEUROSIGMA, INC.: Announces FDA Clearance of Monarch eTNS System as First Non-Drug Treatment for Pediatric ADHD
NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders announced that its Monarch® eTNS® System (Monarch) received FDA clearance as a non-drug treatment for attention deficit hyperactivity disorder (ADHD).
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ABBVIE: Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis
Approval based on clinical trials showing people treated with SKYRIZI™ (risankizumab-rzaa) every 12 weeks - four doses a year after two initial doses - achieved high levels of durable skin clearance at 16 weeks and maintained this response at one year[1-3]
BOSTON SCIENTIFIC CORPORATION: Receives FDA Approval for LOTUS Edge™ Aortic Valve System
Transcatheter Aortic Valve Replacement Technology for Patients with Severe Aortic Stenosis Designed to Minimize Paravalvular Leakage, Offer Controlled Delivery and Repositionability Post Deployment
ALIVECOR: FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device
KardiaMobile® Now The Only Personal ECG to Detect The Three Most Common Heart Arrhythmias
Surgical mesh for transvaginal repair to be taken off the market
Manufactures of surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) must stop selling their product after an order from the Food and Drug Administration.
FDA seeks public input on participation in rare-disease studies
The Food and Drug Administration is set to hold a public meeting on April 29 regarding “Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.”
LONGHORN VACCINES AND DIAGNOSTICS LLC: PrimeStore® MTM opens Sputum-free Molecular Screening for M. tuberculosis Infection
South Africa pilot study demonstrates new broad approach to identifying M. tuberculosis infected patients for further clinical investigation and treatment
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VETOQUINOL USA: Launches Flexprofen™
Generic carprofen chewable tablet developed to treat osteoarthritis symptoms in dogs
MALLINCKRODT PLC: Mallinckrodt Lupus Phase 4 Clinical Study for Acthar® Gel (Repository Corticotropin Injection) Completes Enrollment in Difficult-to-Manage Population
Company continues focus on evidence expansion, potential utility of Acthar Gel in appropriate, underserved patients
BARONOVA, INC.: Announces FDA Approval of the TransPyloric Shuttle® (TPS®) Device
A First-in-Class, Non-Surgical Solution for Obesity Approved for One-Year of Device Treatment, Offering Patients Potentially More Durable Weight Loss and Health Benefits
ANDERSON ADVANCED INGREDIENTS: Commends the FDA's updated allulose guidelines
Anderson Advanced Ingredients® commends the most recent draft guidance by the U.S. Food and Drug Administration (FDA) titled "The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels".
INNOVUS PHARMACEUTICALS, INC.: Announces FDA Approval of New ANDA for Supply of FlutiCare®
Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women's health and respiratory diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has approved abbreviated new drug application (“ANDA”) No. 208024 for Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC) owned by Akorn, Inc. (“Akorn”) (NASDAQ: AKRX). I
SYNERGISTIC THERAPEUTICS LLC: Obtains US Patent for Sublingual Ketamine Treatment for Depression
Synergistic Therapeutics LLC has recently announced issuance of a U.S. Patent for a sublingual antidepressant lozenge with Ketamine, used to treat anxiety, depression, major depressive disorder (MDD), and treatment-resistant depression (TRD).
BIOTECH: FDA Fast Tracking Innovative Breakthrough Therapies For Cancer Patients
A recent headline from a report released by Friends of Cancer Research, made the following eye-opening statement: "ONE OF THE BIGGEST TREATMENT BREAKTHROUGHS IN THE PAST FIVE YEARS WASN'T A DRUG, BUT A LAW."
Blood pressure monitor with EKG available for pre-order
The new Complete blood pressure monitor with EKG capability from Omron Healthcare, in partnership with AliveCor, is now available for preorder in the U.S. on Omron’s website.
Targeted therapy for metastatic bladder cancer approved by FDA
Balversa is the first targeted therapy to receive approval by the U.S. Food and Drug Administration for adult patients with advanced metastatic bladder cancer with the genetic alteration called FGFR3 or FGFR2 that progressed during or after platinum-containing chemotherapy.