Drug Approval | February 25, 2023
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
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
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
The company's consolidated revenues for the quarter grew 36% to Rs. 3,020 crore on the back of robust performance across all its three businesses
Thermo Fisher and Celltrio bring first-in-kind automation platform to address critical scale-up challenges in biotherapeutics RoboCell cell line automation platform
Profit After Tax (PAT) for the quarter ended December 31, 2022 was at Rs. 290.8 crore as compared to Rs. 239.8 crore in the previous corresponding quarter, registering a growth of 21.3% YoY
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