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  1. MRK announced that its blockbuster drug, Keytruda, in combination with Lenvima, received accelerated approval from the FDA as a treatment for advanced endometrial carcinoma. Women with ...

  2. ZBH recently received the FDA’s 510(k) clearance for its meniscal repair device JuggerStitch. Going by UW Medicine’s definition, “arthroscopic meniscus repair is an outpatient surgical ...

  3. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and ...

  4. Biogen continues to develop another AD candidate, BAN2401, in a phase III Clarity AD study. Amgen announced that a three-drug combination regimen of its multiple myeloma (MM) drug, Kyprolis, ...

  5. X Genomics Inc (NASDAQ: TXG) (listed its shares on Nasdaq on Sept. AxsomeTherapeutics Inc (NASDAQ: AXSM) Bioanalytical Systems, Inc. NASDAQ: BASI) BioCardia Inc (NASDAQ: BCDA) Cardiovascular ...

  6. Roche RHHBY announced that the FDA has granted Breakthrough Therapy designation (BTD) to its lymphoma drug Gazyva (obinutuzumab) for a new indication. The agency granted BTD to the drug ...

  7. The FDA accepts Seattle Genetics (SGEN) and Astellas' BLA for enfortumab vedotin under a priority review to treat advanced/metastatic urothelial cancer. A verdict is pending on Mar 15, 2020.

  8. This week, the FDA granted approval to Glaxo's GSK asthma drug, Nucala for pediatric use. Meanwhile, Pfizer PFE, Allergan AGN and Roche RHHBY provided regular pipeline/regulatory updates ...

  9. Breast Cancer Drugs May Inflame Lungs Per FDA Safety Alert

    Zacks via Yahoo FinanceSep 16 12:33 PM

    The FDA approves new warnings about inflammation risk to be added to labels of Pfizer's (PFE) Ibrance, Eli Lilly's (LLY) Verzenio and Novartis' (NVS) Kisqali.

  10. Globus Medical, Inc. GMED has an impressive growth trajectory, courtesy of robust expansion of its product portfolio. Also, it has an expected earnings growth rate of 12% for the next three ...

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