15 March 2024
15 March 2024
Madrigal’s Rezdiffra received an accelerated approval as a treatment for noncirrhotic NASH, also known as MASH.
Andy Molnar, CEO of the Digital Therapeutics Alliance, discusses the latest trends and challenges in the digital therapeutics space.
The FDA's decision is supported by results from the RATIONALE 302 trial, a global, randomised, open-label Phase III study.
AstraZeneca will pay a purchase price of $800m along with a potential milestone payment of $250m.
The new drug application included data from the Phase III eXalt3 study, published in JAMA Oncology in September 2021.
The EMA raised concerns about the lack of long-term data for Novartis Vijoice in its initial bid, as the Swiss company prepares for a new regulatory submission.
The funds will be used to expand the company’s headcount and enhance datasets.
Biotheus is entitled to receive $694m in potential upfront and milestone payments.
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