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- FDA offers guidance for smoother BLA submissions and outlines biosimilar review changesSubmitting a biologics license application requires early interaction with the FDA's Office of Therapeutic Products, careful preparation to avoid technical and administrative mistakes, and keeping…
- Roche halts development of muscle-preserving obesity drug and returns program to ChugaiRoche announced it is ending work on the experimental muscle-building compound known as GYM329, which had been tested together with a GLP-1 based anti-obesity injection. The decision stops the ong…