Xarelto proven to reduce blood clots and medical costs for morbidly obese patients
Xarelto has proved to reduce the risk of recurrent venous thromboembolism (VTE), blood clots, in patients who are also suffering from morbid obesity.
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Bongo Rx may replace the CPAP for treatment of mild to moderate sleep apnea
More than 70 percent of 200 patients with mild to moderate sleep apnea participating in a Qualtrics Survey conducted September 4 though September 11 selected the FDA-approved Bongo Rx as their preferred choice over a traditional CPAP.
GENETECH: FDA Approves Genentech’s Rituxan (rituximab) in Children With Two Rare Blood Vessel Disorders
Rituxan is the first and only FDA-approved treatment for pediatric patients 2 years of age and older living with granulomatosis with polyangiitis or microscopic polyangiitis
U.S. FDA: Approves first treatment for children with rare diseases that cause inflammation of small blood vessels
The U.S. Food and Drug Administration today approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid hormones).
JANSSEN: Announces U.S. FDA Approval of DARZALEX® (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma
Approval represents first and only FDA-approved biologic indicated for newly diagnosed patients who are eligible for a stem cell transplant
U.S. FDA: Approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks
The U.S. Food and Drug Administration today expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve).
MC2 THERAPEUTICS: Announces Submission of New Drug Application to US FDA for Wynzora™ Cream (Calcipotriene 0.005% and Betamethasone Dipropionate 0.064%) for Treatment of Plaque Psoriasis
MC2 Therapeutics, a late clinical-stage pharmaceutical company focused on novel PAD™ Technology-based topical therapies for chronic inflammatory conditions, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for Wynzora™ Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) for the treatment of plaque psoriasis.
ABIOMED: Receives FDA PMA Approval for Impella 5.5 with SmartAssist, a Minimally Invasive, Forward Flow Heart Pump
Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days.
PHARMACEUTICS INTERNATIONAL, INC.: Pii to Manufacture FDA-Approved Hormone Therapy Injection Drug Product
Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the commercial supply of Fulvestrant Injection 250mg/5ml drug product, which was recently approved by the FDA.
PHOENIX MOLECULAR DESIGNS: Receives FDA Clearance to Begin Phase 1/1b Clinical Trial with PMD-026, a First-in-Class RSK Inhibitor, Targeting Advanced Breast Cancer
Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, received clearance from the Food and Drug Administration (FDA) for PhoenixMD's Investigational New Drug (IND) application for its proprietary PMD-026.
V-Wave heart treatment receives manufacturer's second FDA Breakthrough Device Designation
The U.S. Food and Drug Administration (FDA) recently awarded a second Breakthrough Device Designation for V-Wave Ltd.’s interatrial shunt for pulmonary arterial hypertension (PAH).
British American Tobacco supports FDA's anti-vaping efforts
British American Tobacco CEO Kingsley Wheaton recently released a statement addressing the U.S. Food and Drug Administration’s work to prevent minors from vaping.
U.S. FDA: Statement on FDA efforts to encourage patient engagement in medical device clinical investigations
At the U.S. Food and Drug Administration we are committed to keeping patients, their families and caregivers at the center of our work and to deepening their involvement in how we review medical device applications.
U.S. FDA: Statement on final guidance to help advance development of novel treatments for ALS
Over the past few years we’ve witnessed new medical breakthroughs that are altering how diseases are treated in ways that seemed unimaginable just a decade ago.
RENEO PHARMACEUTICALS: FDA Grants Orphan Drug Designation to Reneo Pharmaceuticals for REN001 for Treatment of Fatty Acid Oxidation Disorders
Reneo Pharmaceuticals, a clinical stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the company's lead drug candidate, REN001, for the treatment of fatty acid oxidation disorders (FAOD).
U.S. FDA: Approves first oral GLP-1 treatment for type 2 diabetes
The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise.
Lilly accepted to FDA’s Complex Innovative Trial Designs Pilot Meeting Program
Eli Lilly and Co. was recently accepted into the U.S. Food and Drug Administration’s (FDA) Complex Innovative Trial Designs (CID) Pilot Meeting Program.
Omega passes FDA's initial Establishment Inspection Report
Omega Laboratories Limited, a Canadian-based subsidiary of Nichi-Iko Pharmaceutical Co., Ltd., and Sagent Pharmaceuticals, Inc., recently passed its initial Food and Drug Administration (FDA) Establishment Inspection Report and will now be allowed to manufacture FDA-approved products.
ELYSIUM HEALTH: Announces FDA Acceptance of Investigational New Drug Application to Evaluate BASIS™ for Prevention of Acute Kidney Injury in Surgical Cardiac Patients
Elysium Health, Inc.,™ a life sciences company developing clinically validated health products based on aging research, today announced the acceptance of an Investigational New Drug ("IND") application by the Food and Drug Administration (FDA) to evaluate the efficacy of BASIS™ for the prevention of acute kidney injury (AKI) in surgical cardiac patients.
SOUND PHARMACEUTICALS: FDA grants Fast Track Designation for SPI-1005 in the Treatment of Meniere's Disease
Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request for Fast Track Designation (FTD) involving SPI-1005 in the treatment of Meniere's Disease (MD).