Search Results for FDA News

Showing 1 – 25  of 991

Regulatory Recon: Fresenius to Buy Akorn, German Merck's Biosimilar Busienss; After Trial Failures OncoMed Cuts Half its Staff (25 April 2017) By Michael Mezher - Published 25 April 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: BD to Acquire Bard for $24B; WHO to Pilot GSK Malaria Vaccine (24 April 2017) By Michael Mezher - Published 24 April 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Biotech M&A Falls Off; E&C Presses HHS on Pandemic Flu Plan (21 April 2017) By Zachary Brennan - Published 21 April 2017

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Categories: News, Asia, Europe, US, EC, EMA, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Medical Devices

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Regulatory Recon: Uniqure to Abandon Gene Therapy in EU; Pfizer Subpoenaed Over Saline Shortages (20 April 2017) By Zachary Brennan - Published 20 April 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

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Regulatory Recon: Google's Verily to Launch 10,000 Patient 'Baseline' Study; WHO, Gates Underscore Progress Against NTDs (19 April 2017) By Michael Mezher - Published 19 April 2017

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Regulatory Recon: FDA Approves Roche's Tecentriq for Advanced Bladder Cancer; Cardinal Health to Buy Medtronic Ops for $6.1B (18 April 2017) By Michael Mezher - Published 18 April 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: OncoMed Lung Cancer Drug Fails in Phase II Study; Hanmi Charged for Late Reporting of Fatal Side Effect (17 April 2017) By Michael Mezher - Published 17 April 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Lilly, Incyte RA Drug Baricitinib Rejected; FDA Ends REMS Requirement for Amgen Anemia Drugs (14 April 2017) By Michael Mezher - Published 14 April 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Drug Shortages Can Spur Price Increases for Similar Drugs (13 April 2017) By Zachary Brennan - Published 13 April 2017

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Categories: News, Asia, Europe, US, EMA, FDA, MHRA, WHO, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

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Regulatory Recon: Neurocrine Biosciences' Ingrezza Approved for Tardive Dyskinesia; FDA's Pazdur Discusses New Oncology Center (12 April 2017) By Michael Mezher - Published 12 April 2017

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Regulatory Recon: NICE Says No to BMS' Opdivo for Head and Neck Cancer; SEC Targets Fake Biotech Stock News (11 April 2017) By Michael Mezher - Published 11 April 2017

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Regulatory Recon: David Hung Steps in as Axovant CEO; Stada to Support €4.1B Takeover Offer from Bain Capital and Cinven (10 April 2017) By Michael Mezher - Published 10 April 2017

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Regulatory Recon: FDA Rejects Merck's Bid to Add Heart Data to Januvia Label; Two Gilead HCV Drugs Approved for Pediatric Use (7 April 2017) By Michael Mezher - Published 07 April 2017

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Regulatory Recon: US FDA Approves Drugs Faster Than EMA (6 April 2017) By Zachary Brennan - Published 06 April 2017

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Categories: News, Asia, Europe, US, CFDA, EC, EMA, FDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

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Regulatory Recon: FDA Advisers Vote Against OTC Combos for Minor Stomach Issues; FDA Commissioner Nominee Faces Senate Committee (5 April 2017) By Zachary Brennan - Published 05 April 2017

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Categories: News, Africa, Asia, Europe, US, EC, EMA, FDA, MHRA, NICE, Biologics and biotechnology, Drugs, Medical Devices

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Regulatory Recon: FDA Approves Teva's Huntington's Drug Austedo; Califf Speaks Out Against Trump Budget Proposal (4 April 2017) By Michael Mezher - Published 04 April 2017

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Regulatory Recon: Astellas to Buy Belgian Drug Discovery Co Odega for €500M; BMS Says Immunotherapy Combo Extends Survival in Melanoma (3 April 2017) By Michael Mezher - Published 03 April 2017

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Regulatory Recon: AstraZeneca's Tagrisso Gets Full Approval in NSCLC; Emma Walmsley Takes the Reins at GSK (31 March 2017) By Michael Mezher - Published 31 March 2017

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Regulatory Recon: Novartis Eyes First FDA CAR-T Approval; FDA Rejects Mylan's Generic of GSK's Advair (30 March 2017) By Michael Mezher - Published 30 March 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: FDA Approves New Drugs to Treat MS, Eczema (29 March 2017) By Michael Mezher - Published 29 March 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: FDA Approves Tesaro's Zejula for Ovarian Cancer; Trump Pushes Congress to Cut NIH 2017 Budget (28 March 2017) By Michael Mezher - Published 28 March 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: AZ's Tagrisso First to be Approved Under China's Priority Review Pathway; House Hearing on Device User Fees Set for Tuesday (27 March 2017) By Michael Mezher - Published 27 March 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: House Vote on Healthcare Bill Set for Friday Afternoon; Pfizer, German Merck mAb Gets First Approval for MCC (24 March 2017) By Michael Mezher - Published 24 March 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Fate of Health Care Act Uncertain as Vote Nears; GSK and Regeneron in Deal to Sequence Genes of 500,000 Britons (23 March 2017) By Michael Mezher - Published 23 March 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: FDA Approves Newron's  Xadago as Add-On for Parkinson's Disease; Novartis Heart Drug Serelaxin Fails in Phase III Trial (22 March 2017) By Michael Mezher - Published 22 March 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News