FDA delays action on Lilly’s donanemab, intent on advisory committee meeting
While Lilly’s Alzheimer’s drug was previously expected in Q1 2024, an FDA-mandated review at an unknown date means a decision may be delayed.
11 March 2024
11 March 2024
While Lilly’s Alzheimer’s drug was previously expected in Q1 2024, an FDA-mandated review at an unknown date means a decision may be delayed.
Amylyx’s stocks plummeted by more than 85% after announcing it is considering scrapping the drug due to the trial failure.
Schizophrenia affects approximately one in 100 people globally and presents with diverse symptoms.
Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.
The recall due to CGMP deviations will impact 55,000 bottles of gout medication in the US.
The application submitted to the FDA includes all indications for which XOLAIR is currently approved.
While some biotechs are attempting to develop disease-modifying therapies for amyotrophic lateral sclerosis (ALS), it has proven challenging.
In a Phase III trial, etrasimod demonstrated significant improvements in mucosal healing and symptomatic remission.
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