Articles From: FDA Advisory Committee Panel Votes In Favor Of The WATCHMAN™ Left Atrial Appendage Closure Device to FDA Grants QIDP Fast-Track Designation to RedHill Biopharma's Phase III H. pylori Drug RHB-105


Comprehensive Clinical Data from Randomized Trials Reviewed MARLBOROUGH, Mass.
Sign-up for FDA Advisory Committee Panel Votes In Favor Of The WATCHMAN™ Left Atrial Appendage Closure Device investment picks
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration’s Pulmonary Allergy Drugs Advisory Committee (PADAC) voted 13-2 to recommend approval of KALYDECO ® (ivacaftor) in people with cystic fibrosis (CF) ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory ( CFTR ) gene, which is the indication being reviewed by the FDA.
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NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 8 to 5 that the available data support the approval of Natpara® (rhPTH [1-84]) for the long-term treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, or PTH.
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Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved an updated label for EMBEDA ® (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, for oral use, CII, to include abuse-deterrence studies.
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Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc., (NASDAQ:HALO) today announced that the United States Food and Drug Administration (FDA) approved Baxter’s subcutaneous treatment for adult patients with primary immunodeficiency (PI), HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]. HYQVIA is the first subcutaneous immune globulin (IG) treatment approved for PI patients with a dosing regimen requiring only one infusion up to once per month (every three to four weeks) and one injection site per infusion to deliver a full therapeutic dose of IG.
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Baxter International Inc. (NYSE:BAX) today announced that the United States Food and Drug Administration (FDA) has approved OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (AHA), a very rare and potentially life-threatening acute bleeding disorder.
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Baxter International Inc. (NYSE:BAX) today announced that the United States Food and Drug Administration (FDA) has approved RIXUBIS [Coagulation Factor IX (Recombinant)] for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B.
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Dexcom, Inc. (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its CGM remote mobile communications device: Dexcom SHARE.
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Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM), announced today that the U.S. Food and Drug Administration (FDA) has approved new software for the Dexcom G4 ® PLATINUM CGM.
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AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) approved MOVANTIK ™ (naloxegol) Tablets C-II as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain.
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Allergan, Inc. (NYSE: AGN) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market two new styles, X and L, of the Natrelle ® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and revision surgery.
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- Trulicity, a weekly glucagon-like peptide-1 (GLP-1) receptor agonist, is indicated for adults with type 2 diabetes as an adjunct to diet and exercise - The single-dose pen does not require mixing nor measuring and comes with a no-see, no-handle needle INDIANAPOLIS , Sept.
Sign-up for FDA Approves Trulicity™ (dulaglutide), Lilly's Once-Weekly Therapy for Adults with Type 2 Diabetes investment picks
Approval aligns with Centers for Disease Control and Prevention's recommendations for meningococcal vaccination SWIFTWATER, Pa.
Sign-up for FDA Approves Use of Menactra® Vaccine for Booster Immunization Against Potentially Deadly Disease investment picks
NORTHBROOK, Ill., Oct.
Sign-up for FDA Clears Additional Viral Targets on Verigene Enteric Pathogens Test investment picks
SUNNYVALE, Calif., Sept.
Sign-up for FDA Clears da Vinci(R) System Use in Benign Base of Tongue Resection Procedures investment picks
Siemens Healthcare has announced that the Food and Drug Administration (FDA) has cleared the SOMATOM Scope, a new 16-slice computed tomography (CT) scanner.
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http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=1142090&ProfileId=051205&sourceType=1 AMES, IA --
Sign-up for FDA Gives NewLink Genetics Approval to Proceed to Phase 1 Clinical Studies of Their Ebola Vaccine investment picks
Aradigm Corporation (Nasdaq:ARDM) (the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate, Pulmaquin®, for treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients with chronic lung infections with Pseudomonas aeruginosa .
Sign-up for FDA Grants Fast Track Designation to Aradigm’s Pulmaquin for Non-Cystic Fibrosis Bronchiectasis investment picks
NEW YORK and PETACH TIKVAH, Israel , Oct.
Sign-up for FDA Grants Fast Track Designation to NurOwn™ for the Treatment of ALS investment picks
Under the FDA's Generating Antibiotic Incentives Now (GAIN) Act, the Qualified Infectious Disease Product (QIDP) designation allows for additional five years of market exclusivity in addition to existing exclusivity, Fast-Track status (an expedited development pathway) and Priority Review status (shortened review time for marketing applications) With half of the targeted 120 patients already recruited, top-line data from the ongoing RHB-105 first Phase III study in the U.S. is expected in the second quarter of 2015 RHB-105 is targeting a significantly broader indication than that of existing H.
Sign-up for FDA Grants QIDP Fast-Track Designation to RedHill Biopharma's Phase III H. pylori Drug RHB-105 investment picks
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Articles From: FDA Advisory Committee Panel Votes In Favor Of The WATCHMAN™ Left Atrial Appendage Closure Device to FDA Grants QIDP Fast-Track Designation to RedHill Biopharma's Phase III H. pylori Drug RHB-105
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