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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.

Roche receives FDA acceptance for giredestrant combo NDA

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 ...
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FDA accepts Roche's NDA seeking approval for breast cancer drug

Roche RHHBY announced that the FDA has accepted its new drug application (NDA) for giredestrant, an investigational oral ...
MPR

FDA Accepts NDA for Once-Monthly Olanzapine Injection for Schizophrenia

Using proprietary copolymer technology, TEV-’749 allows for a controlled steady release of olanzapine, a second generation antipsychotic.

Brianna Chickenfry reveals wild new details from Zach Bryan’s $12M NDA

The Barstool Sports personality appeared on Logan Paul’s “Impaulsive” podcast and dubbed Bryan’s relationship with his wife a ...