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About 94,764 results
FDA expands pembrolizumab indication for first-line treatment of NSCLC (TPS ≥1%)
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm635857.htm

Apr 10th, 2019 - On April 11, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1...

OPTIMIZER Smart System - P180036
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm634106.htm

Mar 20th, 2019 - The OPTIMIZER Smart System includes an implantable pulse generator (IPG), a charging system and a programmer. The IPG monitors the heart’s activity and delivers non-excitatory electrical signals (cardiac contractility modulation therapy) to the right ventricle of the heart in patients with chronic heart failure.

VENTANA PD-L1 (SP142) Assay - P160002/S009
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm633972.htm

Mar 10th, 2019 - What is it? It is a test done in a laboratory using samples from triple negative breast cancer patients which doctors use to see if patients have programmed cell death ligand (PD-L1) in their cancer. When is it used? To help doctors decide whether atezolizumab is the best treatment choice for their patients. Atezolizumab is a drug that blocks PD-L1. Doctors use atezolizumab in combination wi...

Filgotinib
https://www.glpg.com/filgotinib

Mar 6th, 2019 - Filgotinib is a highly selective JAK1 inhibitor, discovered and developed by Galapagos using its target and drug discovery technology platform. In more than 1,600 patient years of rheumatoid arthritis (RA) and Crohn's disease clinical study experience, filgotinib has shown a rapid onset of action, potentially best-in-class efficacy and favorable findings on safety and tolerability. From a regul...

FDA Approves BIOTRONIK's Ultrathin Orsiro Stent for the Treatment of Coronary Artery Disease
https://www.orsiro.com/us/newsroom/february-22-2019

Feb 21st, 2019 - BIOTRONIK today announced FDA approval of the Orsiro drug-eluting stent (DES) system. Orsiro is the first and only ultrathin DES to outperform the clinical standard, Xience. Orsiro received CE marking in 2011 and has been used to treat more than one million patients worldwide to date. Orsiro's unprecedented clinical performance in the BIOFLOW-V pivotal trial demonstrated significantly lower ra...

CABLIVI (caplacizumab-yhdp) Prescribing Information
http://products.sanofi.us/cablivi/cablivi.pdf

Feb 5th, 2019 - CABLIVI is a von Willebrand factor (vWF)-directed antibody fragment indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Sangia Total PSA Test - P170037
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm630197.htm

Jan 29th, 2019 - The Sangia Total Prostate Specific Antigen (PSA) Test consists of a Cassette Assembly and a Sample Collector. The Sangia Total PSA Test is used as an aid in the diagnosis of prostate cancer. This new test is the first point-of-care test that can deliver PSA results near where the patient is being evaluated, for example at the doctor's office, instead of waiting for lab analysis. The test can be...

23andMe Receives FDA Clearance for Direct-to-Consumer Genetic Test on a Hereditary Colorectal Cancer Syndrome
https://mediacenter.23andme.com/press-releases/23andme-receives-fda-clearance-for-direct-to-consumer-genetic-test-on-a-hereditary-colorectal-cancer-syndrome/

Jan 21st, 2019 - 23andMe, Inc., the leading personal genetics company, today received FDA clearance for a genetic health risk report on a hereditary colorectal cancer syndrome. The clearance follows the FDA’s authorization for 23andMe’s BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report in March 2018. The MUTYH-Associated Polyposis report was submitted to the FDA using the 510(k) submission pathway, ena...

MORPHABOND™ ER (morphine sulfate) Prescribing Information
https://dsi.com/prescribing-information-portlet/getPIContent?productName=Morphabond&inline=true

Nov 30th, 2018 - MORPHABOND ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

ROXYBOND (oxycodone hydrochloride) Prescribing Information
https://dsi.com/prescribing-information-portlet/getPIContent?productName=Roxybond&inline=true

Nov 30th, 2018 - ROXYBOND is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

bluebird bio’s LentiGlobin™ Gene Therapy Granted Accelerated Assessment by European Medicines Agency for the Treatment of Transfusion-Dependent β-Thalassemia
http://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bios-lentiglobintm-gene-therapy-granted-accelerated

Jul 25th, 2018 - bluebird bio, Inc. (Nasdaq: BLUE) today announced that its investigational LentiGlobin™ gene therapy for the treatment of adolescent and adult patients with transfusion-dependent β-thalassemia (TDT) and a non-β0/β0 genotype, was granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), for its upcoming marketing author...

TIBSOVO® (ivosidenib tablets) Prescribing Information
https://www.tibsovopro.com/pdf/prescribinginformation.pdf

Jul 19th, 2018 - TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test

MORPHABOND ER Medication Guide
https://dsi.com/prescribing-information-portlet/getPIContent?productName=Morphabond%20Med&inline=true

May 31st, 2018 - MORPHABOND ER is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis
https://news.abbvie.com/news/upadacitinib-meets-all-primary-and-ranked-secondary-endpoints-including-superiority-versus-adalimumab-in-phase-3-study-in-rheumatoid-arthritis.htm

Apr 8th, 2018 - AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-COMPARE clinical trial showing that after 12 weeks, upadacitinib (15 mg, once-daily) met the primary endpoints of ACR20a and clinical remissionb versus placebo.1 All ranked secondary endpoints were also achieved versus either placebo or adalimumab (40 mg eve...

ROXYBOND (oxycodone hydrochloride) Medication Guide
https://dsi.com/prescribing-information-portlet/getPIContent?productName=Roxybond_Med&inline=true

Mar 31st, 2017 - ROXYBOND is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as nonopioid pain medicines do not treat your pain well enough or you cannot tolerate them.

MORPHABOND (morphine sulfate) extended-release tablets Prescribing Information
http://inspiriondt.com/wp-content/uploads/2012/08/MorphaBond-PI-02Oct2015.pdf

Oct 30th, 2015 - Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing MORPHABOND, and monitor all patients receiving MORPHABOND for development of these behaviors or conditions. ... Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed MORPHABOND.

ROXYBOND (oxycodone hydrochloride) tablets Prescribing Information
http://inspiriondt.com/wp-content/uploads/2012/08/RoxyBond-Package-Insert-20Apr17.pdf

Oct 30th, 2015 - ROXYBOND™ safely and effectively. See full prescribing information for ROXYBOND. ROXYBOND (oxycodone hydrochloride) tablets, for oral use, CII.

A First-line Oral Treatment for Certain People with Gaucher Disease Type 1
http://www.cerdelga.com/healthcare-professionals.html

CERDELGA is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.

ADEMPAS (riociguat) tablets
http://adempas-us.com/hcp/

Adempas (riociguat). Visit Adempas-US.com to see full safety and prescribing information, including Boxed Warning. Learn about Adempas and the Aim Patient Support Program.