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 The leading web portal for pharmacy resources, news, education and careers October 19, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - October 19, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 81     Next >>     Go To Page:

10/19/17 - FDA approves new gene therapy for blood cancer
The U.S. Food and Drug Administration approved a new form of cell-based gene therapy for adults with certain types of large B-cell lymphoma, marking only the second time a gene therapy has been approved for the disease. The FDA said diffuse large B-cell lymphoma is the most common type of non-Hodgkin's Lymphona in adults and there are approximately
10/19/17 - NVO : Semaglutide Gets Positive Vote In Favour Of Approval From FDA Panel
WASHINGTON- Novo Nordisk said that the Endocrinologic and Metabolic Drugs Advisory Committee or EMDAC of the US Food and Drug Administration voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. Based on the data included in the New Drug Application for semaglutide, the FDA aske
10/19/17 - Yescarta, second blood cancer gene therapy, approved by FDA [The San Diego Union-Tribune]
Oct. 18 A gene therapy treatment for some hard-to-treat lymphomas was approved Wednesday by the U.S. Food and Drug Administration. It was developed by Kite Pharma, which was recently purchased by Gilead Sciences. The first treatment, Kymriah, or, tisagenlecleucel, was approved Aug. 30 for some pediatric and young adult patients with acute lymphob
10/18/17 - Abbott Reports Third-Quarter 2017 Results
Projected full-year adjusted diluted EPS from continuing operations is now $2.48 to $2.50, which represents an increase at the mid-point of the guidance range. In September, Abbott received U.S. FDA approval for its FreeStyle Libre glucose monitoring system as a replacement 1 for finger stick blood glucose monitoring. This revolutionary technolo
10/18/17 - AstraZenecas Imfinzi cancer drug clears another regulatory hurdle [Tehran Times (Iran)]
AstraZeneca PLCs Imfinzi cancer treatment has cleared another regulatory hurdle after the US Food and Drug Administration accepted a supplemental Biologics License Application for the treatment of certain lung cancer patients. Specifically, the application is for the use of Imfinzi in people with stage III unresectable non-small cell lung cancer...
10/18/17 - FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
SILVER SPRING, Md., Oct. 18, 2017/ PRNewswire-USNewswire/ The U.S. Food and Drug Administration today approved Yescarta, a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor T
10/18/17 - FDA Approves Second LLS-Supported CAR T-cell Immunotherapy, A Revolutionary Approach to Cancer Treatment
RYE BROOK, N.Y., Oct. 18, 2017/ PRNewswire-USNewswire/ The Leukemia& Lymphoma Society hails today's U.S. Food and Drug Administration approval of a new, personalized cell therapy that supercharges the patient's immune system to find and kill cancer cells. The therapy, axicabtagene ciloleucel, is the second of this new method of treatment, known a
10/18/17 - FDA Approves Yescarta?, Revolutionary CAR-T Immunotherapy for Non-Hodgkin's Lymphoma Patients
TAMPA, Fla., Oct. 18, 2017/ PRNewswire-USNewswire/ The Food and Drug Administration announced today the approval of Yescarta?, a revolutionary new immunotherapy for adult patients with diffuse large B cell lymphoma, a form of non-Hodgkin's lymphoma. Yescarta is a Chimeric Antigen Receptor T cell therapy, also known as CAR-T. Moffitt Cancer Cent
10/18/17 - FDA clears new Senhance System that can help facilitate minimally invasive surgery [T-break Tech (Middle East)]
Today, the U.S. Food and Drug Administration cleared the Senhance System, a new robotically-assisted surgical device that can help facilitate minimally invasive surgery. "Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery," said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA`s Center
10/18/17 - FDA Clears Robotically-Assisted Surgical Device
The U.S. FDA has cleared the Senhance System, a new robotically-assisted surgical device that can help facilitate minimally invasive surgery. The system, developed by Morrisville, N.C.-based TransEnterix Surgical Inc., is intended for use on adult patients only.
10/18/17 - FDA OKs 2nd gene therapy for blood cancer; 1st for adults
U.S. regulators have approved a second gene therapy for blood cancer - the first one approved for adults. It's a custom-made, one-time treatment for aggressive lymphoma. The Food and Drug Administration on Wednesday approved sales of the therapy from Kite Pharma.
10/18/17 - Glenmark Pharmaceuticals receives ANDA approval for Aprepitant Capsules USP, 40 mg, 80 mg, and 125 mg
Glenmark's current portfolio consists of 127 products authorized for distribution in the U.S. marketplace and 60 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio
10/18/17 - Janssen Announces U.S. FDA Approval of Stelara for the Treatment of Adolescents with Moderate to Sever Plaque Psoriasis
Release date- 13102017- Horsham, Pa.- Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration has approved an expanded indication for STELARA for the treatment of adolescents with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 'Psoriasis can affect many aspects of everyday life
10/18/17 - Kite's Yescarta? (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy
Manufacturing Success Rate of 99 Percent in ZUMA-1 Pivotal Trial with a Median 17 Day Turnaround Time. FOSTER CITY, Calif.& SANTA MONICA, Calif. Kite, a Gilead Company, today announced that the U.S. Food and Drug Administration has granted regular approval to Yescarta?, the first chimeric antigen receptor T cell therapy for the treatment
10/18/17 - Myriad's BRACAnalysis CDx Supplementary PMA Accepted by FDA for Review as a Companion Diagnostic for Lynparza (olaparib) in Metastatic Breast Cancer
Myriad Genetics, Inc., a leader in molecular diagnostics and personalized medicine, today announced that the U.S. The results of the OlympiAD trial were published in the New England Journal of Medicine in June. In Dec. 2014, Myriad received FDA approval for BRACAnalysis CDx to help identify patients with advanced ovarian cancer who are eligible f
10/18/17 - OptiScan Biomedical's OptiScanner 5000 Receives 510(k) Clearance from US Food and Drug Administration for the First Inline Continuous Glucose Monitor in the SICU
The clearance by FDA was based on results from OptiScan's pivotal, multi-center clinical trial in 160 surgical intensive care unit patients comparing the accuracy of the OptiScanner 5000 to industry standard glucose measurement in the ICU. "This clearance by FDA is incredibly gratifying for the entire OptiScan team. We are proud to be the first co
10/18/17 - Positive Developments From Clinical Studies and FDA Approvals Pushing Biotech Stocks to New Highs
The health care sector in general has enjoyed a strong year this year, up 20 percent since January, as many biotechs have the attention of Wall Street ahead of the third-quarter earnings season such as: Moleculin Biotech, Inc., AmpliPhi Biosciences Corporation, Ionis Pharmaceuticals Inc., Abeona Therapeutics Inc., Acadia Pharmaceuticals Inc..
10/18/17 - Respiratory Motion Inc., is excited to announce the launch of the latest ExSpiron 1Xi? Respiratory Monitor
Respiratory Motion, Inc., announced today its plans to launch the newest version of its ExSpiron 1 Xi? Minute Ventilation Monitor at the American Society of Anesthesiologists in Boston, October 21-25 following recent FDA 510 clearance. This new ExSpiron requires no calibration, which greatly expands its range of use. Physicians, nurses, respira
10/18/17 - Semaglutide receives positive 16-0 vote in favour of approval from FDA Advisory Committee
Based on the data included in the New Drug Application for semaglutide, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of semaglutide for the treatment of type 2 diabetes in adults. We look forward to working with the FDA as they complete their review of se
10/17/17 - Department of Veterans Affairs to Provide New Treatment Options for Veterans Suffering from Major Depressive Disorder
Magstim, a pioneer in the study and development of Transcranial Magnetic Stimulation, has received a contract from the Veterans Administration to help treat Major Depressive Disorder in Veterans who have failed to achieve satisfactory improvement from prior antidepressant medication. The device has been approved by the Food and Drug Administratio
10/17/17 - FDA Approves Stelara for Plaque Psoriasis
The US Food and Drug Administration (FDA) has approved ustekinumab (Stelara) for the treatment of adolescents with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, announced Janssen.
10/17/17 - FDA Clears First 7T MRI Scanner
The FDA has cleared the Magnetom Terra MRI scanner from Siemens Healthineersthe first-ever 7 Tesla (7T) MRI cleared for diagnostic imaging. According to company officials, the system's neurological and musculoskeletal applications enable physicians to see functional and anatomical details not visible at lower magnet field strengths.
10/17/17 - FDA clears new robotically assisted surgical device for adult patients
Release date- 16102017- Today, the U.S. Food and Drug Administration cleared the Senhance System, a new robotically assisted surgical device that can help facilitate minimally invasive surgery. 'Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,' said Binita Ashar, M.D., director of the Division of Surgical Devi
10/17/17 - First 7T MRI system receives FDA clearance for clinical use in the United States [Sport360]
Today, the U.S. Food and Drug Administration cleared the first seven tesla magnetic resonance imaging device, more than doubling the static magnetic field strength available for use in the United States. "The overall image quality of MRI improves with higher magnetic field strength," stated Robert Ochs, Ph.D., director of the Division of Radiologi
10/17/17 - GLENMARK DRUG GETS USFDA NOD
Glenmark Pharmaceuticals has obtained final approval from the US FDA for. The tablets are generic equivalent to Merck Sharp and Dohme Corporation's Emend capsules. According to IMS health sales data for the 12 months ended Aug 2017, sales of Emend Capsules, 40, 80, and 125 milligram was about $64.9 million.
Articles(s): 1 - 25 of 81     Next >>     Go To Page:


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