Appili Therapeutics (APLIF) announced that the U.S. Food and Drug Administration has provided positive feedback regarding the development ...

The FDA has accepted a new drug application for the glioma-imaging agent Pixclara, with a decision expected next year. The Food and Drug Administration (FDA) has accepted a new drug application for ...

We expect to submit an investigational new drug application (IND) and non-U.S. applications for ZW220 in the first half of 2025. Zymeworks is a global clinical-stage biotechnology company committed to ...

MELBOURNE, Australia, Oct. 24, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has ...

Ludwig Cancer Research scientists have devised new types of chimeric antigen ... able to dimerize the two chains upon application of a cancer drug called venetoclax. When it binds those external ...

The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application. “With the acceptance of our New Drug Application for LNZ100, we are pleased to be one ...

Environmental conditions appear conducive for some additional development over the next day or so, and a short-lived tropical depression or storm could form before the system moves inland over ...

“This new data shows there is hope, there is progress, and there is an urgent call to action for us all to continue working together across all of society to reduce drug overdose deaths and save ...

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

In addition, the U.S. Food and Drug Administration approved a new test in May where patients can collect their own vaginal samples in the comfort of their homes to test for HPV, streamlining the ...

Weight-loss and diabetes drugs like Ozempic and Mounjaro could be used to treat drug and alcohol addiction in the future ... very different from the outcomes used when researchers test new treatments ...