BlossomHill Therapeutics has secured $100m in a Series B financing round, a significant move to progress the development of its programmes targeting cancer and autoimmune diseases.
The FDA has issued a Complete Response Letter for the New Drug Application of cefepime-taniborbactam, requesting additional chemistry, manufacturing, and controls data.
The FDA's Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.
A Phase I trial studying the therapy is underway after an FDA clinical hold was lifted last year, with initial data expected in 2024.
The immune-mediated inflammatory bowel disease affects approximately 2.6 million people in Europe.
All patients in a trial have been offered the long-acting drug. Drugmaker is betting on injectable treatments for HIV.
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