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  1. EYEG: FDA Approves IDE. We Like Chances of Success of Upcoming OBG-PRK Pivotal Study

    Zacks Small Cap Research via Yahoo FinanceJun 05 14:00 PM

    FDA IDE approval has additional positive implications: FDA IDE approval of this OBG-PRK pivotal study is a significant event as it not only represents a major step towards potential ...

  2. As part of these efforts, the FDA has been working to develop new methods to quantify certain per- and polyfluoroalkyl substances (PFAS) in foods. We have employed these new methods to ...

  3. The warning letters are just one aspect of the FDA's Youth Tobacco Prevention Plan designed to limit youth access to all tobacco products, with a particular focus on youth e-cigarette ...

  4. Merck's Antibiotic Zerbaxa Gets FDA Nod for New Indication

    Zacks via Yahoo FinanceJun 04 14:18 PM

    MRK gained FDA approval for a supplemental new drug application looking for label expansion of its antibacterial medicine, Zerbaxa for two types of pneumonia infections. Zerbaxa, a combination ...

  5. Lilly's Emgality Gets FDA Approval for Cluster Headache

    Zacks via Yahoo FinanceJun 06 13:22 PM

    Eli Lilly and Company LLY announced that the FDA has granted approval to its CGRP antibody, Emgality injection (300 mg) for the preventive treatment of episodic cluster headache in adult ...

  6. AMGN and its biosimilar collaboration partner, Allergan AGN announced that the FDA has approved Kanjinti (trastuzumab-anns), their biosimilar of Roche’s RHHBY breast cancer drug, Herceptin ...

  7. Food and Drug Administration (FDA) held its first public hearing about the safety and regulation of cannabis and cannabis-derived products. At the heart of the hearing were issues of ...

  8. Celgene & Acceleron's BLA for Luspatercept Accepted by FDA

    Zacks via Yahoo FinanceJun 06 20:56 PM

    The FDA has granted Priority Review to the BLA for the treatment of beta-thalassemia and set a target action date of Dec 4, 2019. In addition, the FDA has also set a PDUFA date ...

  9. The FDA Taps IBM for Pharmaceutical Blockchain Pilot

    Motley Fool via Yahoo FinanceJun 13 20:50 PM

    International Business Machines (NYSE: IBM), along with Walmart, Merck, and KPMG, have been chosen to assist the FDA and other drug supply chain stakeholders in developing a blockchain-based ...

  10. "The FDA's ongoing oversight of e-cigarettes and other ENDS products is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related ...

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