FDA Aims To Improve Medical Device Security
The agency has issued proposed draft recommendations to guide incorporation of cybersecurity protections into medical devices at the time of manufacture.
Diagnosis & Disease Information
Brukinsa Approved for Waldenström Macroglobulinemia
The approval was based on data from the phase 3 ASPEN trial.
Iclusig Approved for Resistant or Intolerant Chronic-Phase CML
The sNDA approval is based on efficacy and safety data from the open-label phase 2 OPTIC trial and 5-year data from the phase 2 PACE trial.
Tagrisso Approved as Adjuvant Therapy for Early-Stage EGFR-Mutant NSCLC
The approval was based on data from the double-blind, placebo-controlled phase 3 ADAURA study.
Biosimilar Riabni Gets FDA Approval
The biosimilar has been approved for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, and Microscopic Polyangiitis.
Pfizer, BioNTech COVID-19 Vaccine Gets EUA; First Doses Shipped
The allocation and distribution of vaccine is being managed by the Department of Defense, in partnership with agencies within the Department of Health and Human Services.
FDA Approves Drug for PET Imaging of Prostate Cancer
Approval of Gallium 68 PSMA-11 provides new imaging approach to detect prostate cancer metastasis or recurrence.
Gallium 68 PSMA-11 Approved for Prostate Cancer Detection
The approval was based on efficacy and safety data from 2 prospective clinical trials.
Keytruda Approved for Triple-Negative Breast Cancer
The approval was based on data from the phase 3 KEYNOTE-355 trial that pembrolizumab plus chemotherapy in adults with locally recurrent inoperable or metastatic TNBC, who had not been previously treated with chemotherapy in the metastatic setting.
Cemiplimab Granted Priority Review for Advanced NSCLC
Topline results from the trial showed that compared with chemotherapy, treatment with cemiplimab-rwlc reduced the risk of death by 32% in the overall trial population.
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