Articles From: FCC Head Skeptical of Wireless Consolidation to FDA Approves Addition to CIALIS® (tadalafil) Product Label


2014/2/3
The head of the nation's top telecommunications regulator conveyed skepticism about further consolidation in the wireless industry during a meeting with Sprint Corp.
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By Gautham Nagesh WASHINGTON--The Federal Communications Commission on Thursday said it is open to allowing greater foreign investment in radio and TV stations, but may in exchange ask companies to free up more airwaves for wireless broadband.
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By Gautham Nagesh WASHINGTON--The Federal Communications Commission said Wednesday it will write new rules to prevent Internet service providers from charging companies such as Netflix Inc. or Google Inc. a toll to reach consumers at the highest speeds.
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2014/2/19
WASHINGTON--The Federal Communications Commission said Wednesday that it will craft new rules to prevent Internet service providers from charging companies like Netflix Inc. or Google Inc. a toll to reach consumers at the highest speeds.
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2014/1/14
WASHINGTON (MarketWatch) -- The Federal Communications Commission said it's considering "all available options," including appeal, following a federal appeal's court decision to strike down so-called net neutrality rules.
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2013/8/29
DEARBORN, Mich.
Sign-up for FCE Bank's 2013 Interim Report and Financial Statements Published investment picks
2014/2/19
http://media.marketwire.com/attachments/201310/67049_medicinescompany.jpg http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=1090973&ProfileId=051205&sourceType=1 PARSIPPANY, NJ --
Sign-up for FDA Accepts Filing of the Medicines Company's New Drug Application for Intravenous Antibiotic Oritavancin With Priority Review investment picks
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Supplemental New Drug Application (sNDA) for ELIQUIS ® (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE.
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2014/2/20
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Biologics License Application for V503, its investigational 9-valent human papillomavirus (HPV) vaccine, has been accepted for standard review by the U.S. Food and Drug Administration.
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2014/4/3
http://media.marketwire.com/attachments/201310/67049_medicinescompany.jpg http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=1103697&ProfileId=051205&sourceType=1 PARSIPPANY, NJ --
Sign-up for FDA Accepts the Filing of The Medicines Company's US Biologic License Application for Fibrocaps Hemostatic Agent investment picks
By Joseph Walker The U.S. Food and Drug Administration has become aware of negative cognitive adverse events related to a closely watched group of experimental anti-cholesterol drugs, Sanofi SA said in a regulatory filing Friday.
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By Joseph Walker The U.S. Food and Drug Administration has become aware of cognitive adverse events related to a closely watched group of experimental anti-cholesterol drugs being developed by large drug firms, Sanofi SA said in a regulatory filing Friday.
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2014/2/12
http://media.marketwire.com/attachments/201310/67049_medicinescompany.jpg http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=1089608&ProfileId=051205&sourceType=1 PARSIPPANY, NJ --
Sign-up for FDA Advisory Committee Recommends Against Antiplatelet Therapy Cangrelor investment picks
2013/11/19
SAN RAFAEL, Calif., Nov.
Sign-up for FDA Advisory Committee Recommends Approval for BioMarin's Vimizim(TM) for the Treatment of Patients With Morquio A Syndrome investment picks
2013/9/10
http://media.marketwire.com/attachments/201210/52482_theravance_logo.jpg http://media.marketwire.com/attachments/201212/55322_gsklogo.jpg http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=1049727&ProfileId=051205&sourceType=1 LONDON, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA --
Sign-up for FDA Advisory Committee Recommends Approval in US of Umeclidinium/Vilanterol for the Treatment of COPD investment picks
2014/4/1
VALENCIA, Calif., April 1, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 13 to 1 to recommend that AFREZZA ® (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend that AFREZZA be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes.
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HETLIOZ™ is the First Potential Treatment to be Reviewed by the FDA for Non-24 WASHINGTON , Nov.
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- Treats Seasonal and Year-round Nasal Allergy Symptoms in Adults and Children - PARIS , July 31, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration's (FDA) Nonprescription Drugs Advisory Committee (NDAC) voted 10 to 6, with 2 abstentions, recommending approval of Nasacort ® AQ Nasal Spray (triamcinolone acetonide) for over-the-counter use in the U.S. (Logo:   http://photos.prnewswire.com/prnh/20110616/NY20158LOGO ) " Today's positive NDAC vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers," said Charles Hugh-Jones , MD, MRCP, Chief Medical Officer, Sanofi US.
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AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13-1 that the benefits of dapagliflozin use outweigh identified risks and support marketing of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted unanimously (15-0) that the available data support approval of the once-daily nucleotide analogue sofosbuvir in combination with ribavirin for the treatment of chronic hepatitis C in adult patients with genotype 2 and 3 infection.
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2014/3/31
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) announced today that the U.S. Food and Drug Administration (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of Cubist’s investigational antibiotic SIVEXTRO™ (tedizolid phosphate). In the unanimous 14 - 0 decision, the AIDAC found that substantial evidence of the safety and effectiveness of SIVEXTRO for the treatment of acute bacterial skin and skin structure infections (ABSSSI) was provided.
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2014/3/31
CHICAGO, March 31, 2014 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) announced today that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted 12 to 0 that the Company has provided substantial evidence of the safety and effectiveness of its investigational drug, Dalvance TM (dalbavancin) for injection, for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). While not bound by the guidance provided by the Committee, the FDA will consider the Committee's deliberations as part of its review of the New Drug Application (NDA) for Dalvance, which was accepted for priority review by the FDA in November 2013 with an action date of May 26, 2014.
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By Thomas M.
Sign-up for FDA Advisory Committee Votes Against Changing Painkiller Labels investment picks
2014/3/17
First of Kind Product in the U.S. MONROVIA, Calif.
Sign-up for FDA Advisory Panel Votes in Favor of STAAR Surgical's Visian® Toric Implantable Collamer® Lens, TICL™ investment picks
-- Completion of Pediatric Study Can Lead to Additional Marketing Exclusivity - SEATTLE , Oct.
Sign-up for FDA Agrees with Omeros' Pediatric Study Plan for OMS302 investment picks
2013/10/25
Study Data Shows Cialis 5 mg Initiated with Finasteride Provides Significantly Greater Improvements in Urinary Symptoms of Benign Prostatic Hyperplasia than Placebo with Finasteride INDIANAPOLIS , Oct.
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Articles From: FCC Head Skeptical of Wireless Consolidation to FDA Approves Addition to CIALIS® (tadalafil) Product Label
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