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  • Venetoclax Combination Earns FDA Breakthrough Therapy Designation for . . .
    The FDA has granted breakthrough therapy designation to the combination of venetoclax (Venclexta) plus azacitidine as a potential systemic therapy for patients with treatment-naïve myelodysplastic syndrome (MDS) whose disease is considered to be intermediate-, high-, or very high–risk per the revised International Prognostic Scoring systemic (IPSS-R), according to 2 companies that are
  • FDA Grants Venclexta Onureg a Breakthrough Therapy . . . - Curetoday
    The Food and Drug Administration (FDA) granted a breakthrough therapy designation to Venclexta (venetoclax) plus Onureg (azacitadine) for the treatment of patients with untreated intermediate-, high- and very high-risk myelodysplastic syndrome (MDS), according to Roche, the pharmaceutical company that is co-developing the drug with AbbVie
  • AbbVie Provides Update on VERONA Trial for Newly Diagnosed Higher-Risk . . .
    NORTH CHICAGO, Ill , June 16, 2025 PRNewswire -- AbbVie (NYSE: ABBV) announced the global Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet the primary endpoint of overall survival (OS) with a hazard ratio (HR) of 0 908; stratified log-rank, p=0 3772
  • FDA Breakthrough Therapy Designation Granted to Venetoclax Azacitidine . . .
    The FDA has granted breakthrough therapy designation (BTD) to the combination of venetoclax (Venclexta) and azacitidine (Vidaza) for the treatment of adult patients with previously untreated intermediate-, high- and very high-risk myelodysplastic syndromes (MDS) per the revised International Prognostic Scoring System (IPSS-R), according to a press release issued by Roche 1
  • FDA Grants Venetoclax Breakthrough Designation in AML
    Michael Severino, MD Venetoclax has received an FDA breakthrough therapy designation for use in combination with hypomethylating agents in treatment-naïve patients with acute myeloid leukemia
  • FDA Grants Breakthrough Therapy Designation to Venetoclax for Higher . . .
    “This Breakthrough Therapy Designation underscores the need for more treatment options for these patients and the utility of venetoclax to potentially treat different forms of blood cancer ” Venetoclax is a first-in-class medication that selectively binds to and inhibits the B-cell lymphoma-2 protein, which prevents cancer cells from
  • AbbVie Provides Update on VERONA Trial for Newly . . . - Morningstar
    VENCLEXTA® (venetoclax) Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines Today, our expansive oncology
  • Fixed-Duration Acalabrutinib Combinations in Untreated Chronic . . .
    Whether fixed-duration acalabrutinib–venetoclax (with or without obinutuzumab) would result in better progression-free survival than chemoimmunotherapy in patients with untreated chronic
  • BTK Inhibitors In CLL: New Clinical Evidence Reshapes First-Line . . .
    Acalabrutinib-Venetoclax (AV): Oral acalabrutinib 100 mg twice daily (cycles 1-14); oral venetoclax daily (cycles 3-14 with 5-week dose ramp-up) Pirtobrutinib represents a breakthrough as the first non-covalent BTK inhibitor that binds distant from the C481 residue This structural innovation enables activity regardless of C481 mutation status
  • Venetoclax (VENCLEXTA®) Granted US FDA Breakthrough Therapy Designation . . .
    Venetoclax (VENCLEXTA®) Granted US FDA Breakthrough Therapy Designation (BTD) in Higher Risk Myelodysplastic Syndrome (MDS) - This is the sixth BTD granted for venetoclax as AbbVie continues to





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