28 November 2024
28 November 2024
The president of nonprofit Galactosemia Foundation has urged the FDA to reconsider its decision.
The Norse Eight trial was part of the data requested by the FDA after the agency rejected the BLA for the company’s Lytenava last year.
With expected sales estimated to exceed $126 billion by 2030, this drug category presents a lucrative market.
The European Commission’s decision is based on two Phase III trials where Tevimbra plus chemotherapy improved overall survival.
Asthma research is beginning to borrow from oncology’s advances in RWE and registries.
There are currently no available treatment options for any form of frontotemporal dementia that have been approved by the EMA or FDA.
The EC's decision follows the outcomes of two positive Phase IIb trials.
The decision is based on the findings from the randomised, placebo-controlled SELECT trial.
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