FDA plans 19 public meetings in October
Nineteen public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for October, the FDA reported.
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Novartis' Kisqali demonstrates improvement in overall survival in MONALEESA-3 trial
Novartis recently reported results from the MONALEESA-3 trial, the largest to evaluate a CDK4/6 inhibitor plus fulvestrant as initial therapy in postmenopausal women (N=726), which showed that CDK4/6 inhibitor Kisqali (ribociclib) demonstrated statistically significant improvement in overall survival (OS).
Lilly announces successful clinical trial for thyroid cancer treatment LOXO-292
Eli Lilly and Company recently announced that results of the LIBRETTO-001 clinical trial intended to support the registration of oral selpercatinib monotherapy, also known as LOXO-292, were presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain.
EPICA INTERNATIONAL, INC.: Announces U.S. FDA 510(k) Clearance for its Multi-modality, Mobile Computed Tomography Imaging Platform, SeeFactorCT3™
Epica International, Inc. (Epica), received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SeeFactorCT3™ Imaging Platform. SeeFactorCT3™ consists of 3 integrated imaging systems: CT, Fluoroscopy and Digital Radiography; a detachable patient table/chair, and sterile drape for interventional procedures. FDA clearance allows Epica to market these products in the United States.
HERON THERAPEUTICS: Resubmits New Drug Application to FDA for HTX-011 for the Management of Postoperative Pain
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. The Company anticipates a 6-month review by the FDA.
NATIONAL KIDNEY FOUNDATION: FDA Approves New Drug to Treat Diabetes-Related Kidney Disease
The National Kidney Foundation Statement about INVOKANA® (Canagliflozin)
JANSSEN PHARMACEUTICAL: U.S. FDA Approves INVOKANA® (canagliflozin) to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes (T2D) and DKD
INVOKANA® is the only diabetes medicine indicated to slow the progression of diabetic nephropathy (also known as DKD) and reduce the risk of hospitalization for heart failure in patients with T2D and DKD
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.
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
FDA taken to task over opioid approval process
Back in June, the U.S. Food and Drug Administration (FDA) released a draft guidance for overhauling the opioid approval process, which one member of the audience said was woefully inadequate.
Expanded recall set for blood pressure medication Losartan
Torrent Pharmaceuticals recently announced it was expanding its recall for Losartan potassium tablets and Losartan potassium/hydrochlorothiazide tablets.
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).
Torrent's recall of drug to treat hypertension expanded
The recall of medications manufactured by Torrent Pharmaceuticals Ltd. to treat high blood pressure conditions has been expanded, the U.S. Food and Drug Administration reported.
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.