News | March 01, 2023
AstraZeneca expands its portfolio by bringing rare disease therapy for patients in India
Receives regulatory approval for its molecule ‘Selumetinib’ in India
Receives regulatory approval for its molecule ‘Selumetinib’ in India
Receives Subject Expert Committee recommendation to bring new therapies of Pompe, ASMD to India
Dr. Adams brings more than two decades of experience leading the manufacturing of biologic and gene therapies at all stages of development.
This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
The new sterile filling line meets cGMP aseptic filling regulatory requirements
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
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Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI
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