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  1. 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 ...

  2. 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 ...

  3. Medtronic plc MDT recently obtained the Breakthrough Device designation from the FDA for its Valiant TAAA Stent Graft System, designed for the minimally invasive repair of thoracoabdominal ...

  4. AstraZeneca's Triple-Combo COPD Inhaler Gets CRL From FDA

    Zacks via Yahoo FinanceOct 02 11:05 AM

    AstraZeneca plc AZN announced that the FDA has given a complete response letter to its new drug application (NDA) looking for approval of its investigational triple combination therapy ...

  5. 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 ...

  6. 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 ...

  7. 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 ...

  8. 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 ...

  9. The FDA approved Gilead’s supplemental New Drug Application (sNDA) for Descovy under a Priority Review designation. Importantly, Descovy for PrEP indication provides a new ...

  10. "I will grant the Vapor Associations' Motion to intervene exclusively for the limited purpose of filing an appeal of the May 15, 2019 Memorandum. "Here, the businesses represented by the Vapor ...

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