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FDA accepts Beren Therapeutics’ NDA for Niemann-Pick disease
The submission includes data indicating a meaningful survival benefit for infantile-onset NPC patients treated with adrabetadex.
The FDA accepted a supplemental new drug application to expand the indication for Ryzumvi to include the treatment of ...
The NDA is based on results from the Phase III evERA Breast Cancer study. Credit: NMK-Studio / Shutterstock.com. (NMK-Studio / Shutterstock.com.) Roche has obtained acceptance from the US Food and ...
The FDA accepted the new drug application for iberdomide based on minimal residual disease negativity benefit shown in the EXCALIBER-RRMM trial.
Using proprietary copolymer technology, TEV-’749 allows for a controlled steady release of olanzapine, a second generation antipsychotic.
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