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  1. Medtronic (MDT) Gets FDA Nod to Study Intrepid TMVR System

    Zacks via Yahoo FinanceSep 30 14:06 PM

    Medtronic plc MDT received FDA permission to initiate an early feasibility study (EFS) for its Intrepid transcatheter mitral valve replacement (TMVR) system, which uses a minimally-invasive ...

  2. The FDA issued a complete response letter to AstraZeneca’s AZN triple-combo inhaler, PT010 while granting approval to Roche’s RHHBY Rituxan to treat pediatric patients two years and older ...

  3. Abbott Laboratories ABT recently received FDA approval for its Proclaim XR recharge-free neurostimulation system for people with chronic pain. Following the approval, Abbott will be able ...

  4. It was the most significant change to the food safety framework in decades and was an important step that gave the FDA new authorities to help fulfill our obligation to protect consumers ...

  5. Pfenex Inc (NYSE: PFNX) has a key binary event coming up: mark your calendar for Oct. 7, when the FDA is scheduled to issue its verdict on the company's lead drug candidate. Through its ...

  6. FDA and DEA warn website operators illegally selling opioids

    PR Newswire via Yahoo FinanceSep 30 16:15 PM

    "As the FDA works to forcefully tackle the opioid crisis on all fronts, we cannot allow rogue online pharmacies to continue to fuel the crisis by illegally offering opioids for sale and ...

  7. Roche Holding AG RHHBY announced that the FDA approved the label expansion of Rituxan (rituximab). The agency approved the drug, in combination with glucocorticoids, for the treatment ...

  8. Pfenex Gets FDA Seal of Approval For Amgen's Forteo Biosimilar

    Benzinga via Yahoo FinanceOct 07 14:36 PM

    The FDA has approved its NDA for PF708 under the 505(b)(2) regulatory pathway, with Amgen, Inc. NASDAQ: AMGN)'s Forteo as the reference drug.

  9. Abbott (ABT) Gets FDA Nod for New Troponin-I Blood Test

    Zacks via Yahoo FinanceOct 02 13:48 PM

    Abbott Laboratories ABT recently attained the FDA approval for its ARCHITECT STAT High Sensitivity Troponin-I blood test. This is one of the most meticulously-researched troponin diagnostic ...

  10. FDA awards two grants for natural history studies in rare diseases

    PR Newswire via Yahoo FinanceOct 08 15:57 PM

    The FDA is providing over $4.1 million over the next four years to fund these studies. Information from natural history studies can facilitate design of efficient clinical trials to test ...

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