Medical Device | May 05, 2023
Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA
Pheezee is designed to assess musculoskeletal and neuromuscular health.
Pheezee is designed to assess musculoskeletal and neuromuscular health.
The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
Organ Transplants triple across the country; rise from 5000 (2013) to more than 15000 in 2022
Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma
This approval reflects Biocon Biologics' compliance with the highest international regulatory standards
Cooperative agreement with U.S. Government to advance U.S. biopharma industry and ensure pandemic preparedness
The company will submit its comprehensive response on these observations to the US FDA within the stipulated time
Bridging the gap between histopathology and molecular pathology
This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology
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