CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma
Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma
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
Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea
Icosapent Ethyl Capsules are indicated as an adjunct to diet to reduce triglyceride levels
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
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
The acquisition is a crucial step in LTS' strategy to broaden its portfolio of drug delivery platforms.
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