欧洲药监局2021年度报告EMA :2021-annual-report-european-medicines-agency_en.pdf,ANNUAL REPORT 2021 The European Medicines Agency’s contribution to science, medicines and health in 2021 An agency of the European Union All photographs are copyright protec
In March 2021, GB492 submitted an IND application to the National Drug Administration, and in May 2021, GB492 obtained approval from IND to conduct a phase 1 clinical trial to evaluate the safety and initial efficacy of GB492 monoclonal treatment in combination with PD- (L) 1 monoclonal anti...
The preliminary clinical safety and efficacy results of phase I/II study has been presented at the annual meeting of the 65th American Society of Hematology (ASH). The phase I/II clinical trial of GB263T (EGFR/cMET/cMET, TsAb) has completed dose escalations of 1,680mg, radiographic ...
CSL’s pipeline also includes Life Cycle Management projects that address regulatory post-marketing commitments, pathogen safety, capacity expansions, yield improvements, and new packages and sizes.CSL Limited Annual Report 2021/22 12 Our Product Portfolio CSL Behring We meet patients’ needs using the...
This news release contains forward-looking statements, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease...
(department) Antibody-Drug Conjugates Energy Based Device Business Development Earnings Before Interest, Taxes, Depreciation and Amortization Environment, Health, Safety International Multi-center Clinical Trial Over The Counter Drugs that require medical prescriptions issued by physicians to be bought and ...
This last group was started immediately after we had received approval of the report we had submitted to Läkemedelsverket (the Swedish regulatory authority) - showing that there were no safety concerns appa- rent from any of the 36 previously-treated patients. In view of this timing, we ...
Long term safety and efficacy data have submitted to the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Development of other clinical products P53 Y220C activator JAB-30355: The IND has been approved by U.S. FDA (Food and Drug Administration), and phase I clinical trial ...
from initial studies, we launched a phase III clinical trial to assess the efficacy and safety of octagam® 10% in COVID-19 patients with severe disease progression. This study was approved by the FDA in May under an IND application and is due to be completed in the first quarter of ...
Conclusion: Consolidative Durvalumab is recommended as per PACIFIC clinical trial with significant benefit in median progression-free survival of 16.8 months as compared to placebo. Our real-world analysis in our ongoing study with 13 patients to date has shown a median duration of treatment of 7 ...