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news.Alkermes’ alixorexton secures FDA and EC orphan designations
The FDA granted the status to alixorexton for idiopathic hypersomnia while the EC approved the designation for narcolepsy. In the US, the ODD offers incentives such as tax
The FDA granted the status to alixorexton for idiopathic hypersomnia while the EC approved the designation for narcolepsy. In the US, the ODD offers incentives such as tax
This approval is said to be the first in the UK for a needle-free adrenaline treatment for children aged four years and older, weighing between 15kg and less
Under the deal, Simcere will provide funding for exploratory research on a first-in-class novel molecule in the respiratory field. If the research is successful, Simcere will have the
This approval covers patients with ccRCC who are at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions. This marks the
The approval is based on data from one pivotal Phase III trial (AK111-301) and three additional supportive studies. Study results showed that gumokimab delivered rapid and strong efficacy.
The application covers patients with stage III colon cancer characterised by deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR) or microsatellite instability-high (MSI-H). The FDA is anticipated to make
The collaboration follows a successful pilot phase, where XtalPi’s integrated quantum physics and AI algorithms achieved improved hit rates, highlighting the platform’s capability to address the complex metabolic target.
EMA has now begun reviewing its use in adults following a non-cardioembolic ischaemic stroke or a high-risk transient ischaemic attack (TIA). The validation confirms the application is complete
Upon completion of the transaction, Ignite will separate from Aditxt and is expected to become an independent public company via the establishment of a new holding entity, anticipated
The programme will investigate the ways in which AI can enhance the evaluation of precision and safety, better forecast risks, and identify impacts that current methods might overlook.